Composition for use in treatment and / or prevention of chronic musculoskeletal pain including chronic low back pain, chronic non-specific low back pain, osteoarthritis or other chronic musculoskeletal pain conditions comprising delta-9-tetrahydrocannabinol and terpenes

Abstract

The present invention relates to a composition for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non- specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma- terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The invention also relates to a pharmaceutical formulation for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising such a composition. The invention further relates to methods for treatment and or / prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. The invention further relates to kits comprising such a composition.

Description

COMPOSITION FOR USE IN TREATMENT AND / OR PREVENTION OF CHRONIC MUSCULOSKELETAL PAIN INCLUDING CHRONIC LOW BACK PAIN, CHRONIC NON-SPECIFIC LOW BACK PAIN, OSTEOARTHRITIS OR OTHER CHRONIC MUSCULOSKELETAL PAIN CONDITIONS COMPRISING DELTA-9- TETRAHYDROCANNABINOL AND TERPENESThe present invention relates to a composition for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic nonspecific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene, and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alphapinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gammaterpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The invention also relates to a pharmaceutical formulation for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising such a composition. The invention further relates to methods of treatment and or / prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. The invention further relates to kits comprising such a composition.The main active substance that makes Cannabis valuable as an herbal medicine for the treatment of different pain conditions is delta-9-tetrahydrocannabinol (THC) which is present in the Cannabis plant predominantly as carboxylated 9-tetrahydrocannabinolic acid (THCA). THC belongs to the substance class of cannabinoids, comprising amongst THC of a variety of chemically and pharmaceutically related individual cannabinoid substances. In addition, it is well-known that other constituents of the Cannabis plant, especially terpenes, may act synergistically with THC and therefore may increase the analgesic effects of THC containing Cannabis extracts. Terpenes, such as alpha-bisabolol, beta-caryophyllene and beta-myrcene are major constituents of many plant resins and have been used in traditional medicine for centuries due to their medicinal properties.The pharmacological effects of isolated THC and various Cannabis extracts containing THC and different mixtures of other Cannabis derived substances have been compared in animal and human studies. It was found that the pharmacological effects of Cannabis extracts were two to four times greater than expected from their actual THC content (Carl in i et al. 1974, British Journal of Pharmacology, 50(2), 299-309), indicating that other Cannabis derived substances have the potential to significantly enhance the pharmacological effects of THC. However, it remains unknown which other Cannabis derived substances may cause these synergistic effects. The presence of unidentified powerful synergism in Cannabis extracts causing far greater activity than THC alone, has also been reported in a study investigating the cataleptic activity of THC after oral administration to mice (Fairbairn & Pickens, 1981 , British Journal of Pharmacology, 72(3), 401-409). Further, the analgesic activity of a Cannabis extract compared to isolated THC has been studied in rat models of neuropathic pain and mechanical allodynia (Comelli et al. 2008, Phytotherapy Research, 22(8), 1017-1024). The Cannabis extract, containing cannabinoids and other non-cannabinoid fractions (such as terpenes) provided better antinociceptive efficacy than THC alone. The repeated treatment with isolated THC, administered at the same dose present in the extract, displayed only a partial effect and a lack of efficacy on nociceptive behavior. It was suggested that the pharmacological contribution of non-cannabinoid compounds to the analgesic effect might be due to the presence of analgesic terpenes (such as myrcene) and / or some anti-inflammatory terpenes (such as myrcene, beta-caryophyllene, alpha pinene). However, different Cannabis extracts differ greatly in their composition and have not been consistently superior in terms of analgesic efficacy when compared to isolated THC (Chesher et al. 1973; British Journal of Pharmacology, 49(4); 588-594). A dose-dependent antinociceptive effect has been reported for both THC and a Cannabis extract in mice using the hot-plate method with THC being more potent than the Cannabis extract.The analgesic effects of THC and Cannabis extracts have further been investigated in several controlled clinical trials. Isolated THC as well as Cannabis extracts have shown some positive results in the treatment of neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain (Bridgeman M.B. and Abazia D.T., P&T 2017, 42(3), pp.180-188). However, the overall quality of evidence remains low and neither THC nor Cannabis extracts have consistently shown to be effective in reducing pain (Barakji et al. 2023, PloS one vol. 18,1 e0267420, doi:10.1371 / journal. pone.0267420). In addition, there is a lack of primary research investigating Cannabis extracts as a potential treatment for chronic musculoskeletal pain conditions, such as chronic non-specific low- back pain.In conclusion, available research comparing the analgesic effects of isolated THC to different Cannabis extracts has shown that some specific Cannabis extracts may have superior analgesic properties compared to isolated THC due to synergistic effects between different constituents, such as cannabinoids and terpenes, within the Cannabis extracts. However, the exact compounds responsible for these synergistic effects remain largely unknow and thus clinical data on the analgesic effects of one extract cannot be extrapolated to another extract. Additionally, available clinical studies only contain very limited information on the composition of the respective Cannabis extract and most often only states the THC content. Thus, a skilled person is not able to predict the analgesic effects of a new Cannabis extract.Chronic musculoskeletal pain (CMP), particularly chronic lower back pain, is the leading cause of disability across the globe (WHO 2023, Musculoskeletal Conditions. https: / / www.who.int / news-room / fact-sheets / detail / musculoskeletal-conditions, Published 2019. Accessed 27.07.2023). Roughly a third of the world's population experiences some type of CMP, making it the most common type of chronic pain. Chronic musculoskeletal pain is characterized by pain in muscles, bones, joints, tendons, ligaments and adjacent connective tissue that lasts for more than 3 months. CMP involves more than 150 diseases of the human motor system, including common chronic joint pain, neck and shoulder pain, low back pain, limb pain, spinal pain, fibromyalgia and myofasciitis. While the majority of musculoskeletal pain is categorized as somatic, it does not rule out the simultaneous occurrence of other types of pain syndromes, such as neuropathic or visceral pain.According to the 11 th edition of the International Classification of Diseases (ICD-1 1 ), CMP is divided into chronic primary musculoskeletal pain and chronic secondary musculoskeletal pain. Chronic primary musculoskeletal pain cannot be attributed directly to a known disease or damage process, such as chronic non-specific low back pain.Chronic secondary musculoskeletal pain is a kind of CMP arising from a known disease and is commonly due to several main causes: persistent local or systemic inflammatory diseases caused by crystal deposition, infection, autoimmune or autoinflammatory processes; local musculoskeletal structural changes; musculoskeletal problems caused by neurological diseases, such as muscular hypertonicity in Parkinson disease.Chronic musculoskeletal conditions include conditions that affect: one or multiple body areas or systems, such as back and neck pain or widespread pain conditions (e.g., fibromyalgia) joints, tendons and / or ligaments, such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, spondylarthritis bones, such as osteoporosis and, osteopenia muscles, such as sarcopeniaOf those, the most prevalent CMP conditions are:1. chronic low back pain (CLBP), especially non-specific chronic low back pain (NSCLBP)2. arthritis, especially osteoarthritis (OA)3. osteopenia and osteoporosis4. fibromyalgiaOsteoarthritis (OA) is the most common form of arthritis in the world. OA is a multifactorial, degenerative disease of joints, tendons and / or ligaments, which leads to a progressive remodeling of the joint structures and is associated with painful functional limitations and even extensive loss of function of the affected joints. The weight-bearing joints, such as knees, hips, and spine are the most affected appendicular joints, but OA can also impact hands, neck, and toes. The disease onset is typically gradual and usually occurs in individuals over the age of 50, though younger people may also be affected due to injury or overuse. Common symptoms include joint pain, tenderness, stiffness, inflammation, and decreased flexibility.Osteopenia and osteoporosis are both conditions characterized by low bone mass, differing in degree of seventy. Osteopenia describes a decrease in bone mineral density below normal reference values, yet not low enough to meet the diagnostic criteria to beconsidered osteoporotic. The natural bone loss that occurs gradually during adulthood is considered to be the cause of primary forms of osteopenia and osteoporosis. Secondary causes serve to accelerate this process and include lifestyle factors such as alcohol use disorder, smoking, sedentary lifestyle, thin body habitus as well as medical conditions such as hyperparathyroidism, anorexia, malabsorption syndromes, hyperthyroidism, chronic renal failure, hypogonadism, amenorrhea / oligomenorrhea, early onset menopause, and chronic conditions resulting in calcium and / or vitamin D deficiencies. Osteoporosis itself is usually not painful, but broken bones in the spine as consequence of low bone mineral density are a very common cause of chronic long-term musculoskeletal pain.Fibromyalgia (FMS) is a chronic musculoskeletal pain condition that causes widespread pain. FMS was included in the American College of Rheumatology (ACR) 1990 classification criteria by chronic pain in multiple body regions and tenderness of at least 11 / 18 tender points defined. Core symptoms of FMS are chronic pain in several body regions and several regions of the body, sleep disturbances or non-restorative sleep and fatigue or tendency to exhaustion (physical and / or mental). Several pathophysiologic changes are associated with FMS without clarification of the cause-effect relationship. These include disturbances in central pain processing, hyporeactivity of the hypothalamic-pituitary-adrenal axis, disruption of the growth hormone system, increased proinflammatory and decreased anti-inflammatory systemic cytokine profiles, and alterations in the dopaminergic and serotonergic systems.Low back pain (LBP) is the most common musculoskeletal painful condition that many people experience at some point in their lives. It is defined as pain in the area of the posterior aspect of the body from the lower margin of the 12th ribs to the lower gluteal folds with or without pain referred into one or both lower limbs. The global point prevalence of LBP is estimated to be 9.4%, while prevalence and disease burden increase with age. Lower back and neck pain was the leading global cause of disability in 2015 in most countries in the Global Burden of Diseases, Injuries, and Risk Factors Study 2015 (GBD, 2016). LBP can be a symptom of many different underlying conditions, diseases or injuries. For example, a muscle sprain in the lower back is usually followed by a sudden jolt of pain. However, many people with LBP are affected by non-specific low back pain (NSLBP), where no specific problem or disease can be identified as to the cause of the pain (Hartvigsen J et al., Lancet 2018;391 :2356-67).Low back pain can reoccur regularly and can last for several months or even years. Low back pain that is persistent or long term, for more than 3 months, is known as chronic low back pain (CLBP). Chronic low back pain (CLBP) can originate from various structures in the back and can be traced in some cases to a specific bodily structure, such as muscles, joints, tendons and / or ligaments, bones or discs. However, in many cases, the precise cause of chronic low back pain remains unidentified and is known as “chronic non-specific low back pain” (CNSLBP) (National Institute of Neurological Disorders and Stroke. Low back pain fact sheet, 2020). Where the pain originates may not necessarily explain the degree of pain, as it can differ from person to person. The pain may be mild or it can be so severe that the affected person is unable to move. The intensity and frequency of low back pain is very often influenced by psychological components such as stress, depression and anxiety (Hartvigsen J et al., Lancet 2018;391 :2356-67). CLBP can involve different types of pain. It often involves nociceptive pain and neuropathic pain components (Mick G et al., Pain Manag 2012;2:71-7).Non-opioid analgesics (especially non-steroidal anti-inflammatory drugs) for pain management of patients suffering from CMP, including CLBP exist, but for many patients such therapies have not led to sufficient or consistent pain relief, or they are unsuitable due to contraindications or tolerance. For this patient group, opioid analgesics are currently the only pharmacologic treatment available. The efficacy of opioids in treating CMP varies between different opioid treatments. In case of CLBP, for Tapentadol one study reported a 30% response rate of 39.7% and a 50% response rate of 27.0% (Buynak R. et al., Expert Opin Pharmacother. 2010;11 (11 ): 1787-1804). For Oxycodone, the same study reported a 30% response rate of 30.4% and a 50% response rate of 23.3%. A different study reported a 30% response rate of 57% and a 50% response rate of 35% for Tapentadol (Christoph, A. et al., Pain 2017, 158(9):p 1813-1824). For the opioid Tramadol, a further study reported a 30% response rate of 46.7% and a 50% response rate of 26.2% (Uberall MA. et al., Current Medical Research and Opinion 2012, 28:10, 1617-1634). Further, a review on the use of opioids for pain management in CLBP reported a 30% response rate of 51 .1 % and a 50% response rate of 41 .0% (Petzke F. et al., Eur J Pain. 2020;24:497-517).However, opioids are associated with considerable long-term side effects. Opioid-induced constipation, which is known to be the most common side effect of an opioid therapy witha prevalence ranging from 41 to 81 %, is rated by patients as the most bothersome symptom that has a great impact on their quality of life and social interactions (Buynak R. et al., Expert Opin Pharmacother. 2010;11 (11 ): 1787-1804, Baron R. et al., Pain Practice. 2016; 16(5):580-599, Khoromi S. et al., Pain 2007; 130(1 -2):66-75, Kalso E. et al., Pain 2004; 112(3):372-380, Bell TJ. et al., Pain Med. 2009; 10(1 ):35-42). Since tolerance does not develop for opioid-induced constipation (OIC) and symptoms rather increase than decrease overtime, OIC not only significantly impairs patients’ quality of life but also often encourages treatment discontinuation (Abramowitz L. et al., J Med Econ. 2013; 16(12): 1423-1433). The impairment of gastrointestinal function is based on opioids activating the p (gamma)-opioid receptors in the enteric nervous system (ENS), leading to the following effects in the gastrointestinal tract and the development of OIC: increased muscle tone (inhibition of bowel emptying), decreased peristalsis (delayed intestinal passage), and increased absorption of liquid (hardening of the stool). Up to one-third of patients report having interrupted, reduced, or stopped opioid use to relieve symptoms of constipation (Andresen V. et al., Arzneiverordnung in Der Praxis 43 (1 ) Jan 2016, Cook SF. et al., Aliment Pharmacol Then 2008;27(12):1224-1232). For patients, OIC means significant limitations in physical and mental well-being and activities of daily living, reduced quality of life and increased use of health services (Christensen HN. et al., Scand J Pain. 2016; 11 : 104-110, Fernandes AW. et al., Am Health Drug Benefits. 2016;9(3):160- 170). In addition, long-term intake of opioids often leads to development of hyperalgesia and tolerance, which is associated with a decrease in effectiveness and the need to continually increase the dose over time.Moreover, the high risk for abuse, dependency and overdoses leading to opioid-induced respiratory depression (OIRD), often ending fatal, further limits the use of opioids. According to a statistic from 2021 , 82% of all drug overdose deaths in the US involved at least one opioid. As a consequence, many clinical practice guidelines conclude that the potential harms of opioids do not outweigh potential benefits and thus recommend against the use of opioids in chronic musculoskeletal pain, CLBP, CNSLBP, osteoarthritis and / or other specific musculoskeletal conditions.However, due to a lack of alternatives, opioids are still the most frequently prescribed analgesics for patients with chronic musculoskeletal pain, including CLBP and / or CNSLBP, osteoarthritis and / or other specific musculoskeletal conditions. Thus, there is an urgent medical need for novel non-opioid analgesic drugs that provide pain relief withlittle to no side effects. Especially novel analgesics indicated for pain conditions like chronic musculoskeletal pain, CLBP, CNSLBP, osteoarthritis and / or other specific musculoskeletal conditions may present the greatest opportunity to avoid long-term opioid use and to reduce the risk for addiction and fatal overdoses.The present invention meets this demand by providing a composition and a pharmaceutical formulation for use in the treatment and / or prevention of chronic musculoskeletal pain, chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and betacaryophyllene, and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, betapinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol.Surprisingly and unexpectedly, the present inventors found that that anti-inflammatory activity is enhanced when THC and the exemplary terpenes alpha-bisabolol and guaiol are administered in a specific THC / alpha-bisabolol and THC / guaiol ratio in a combinatory treatment when compared to a treatment with either THC, alpha-bisabolol or guaiol alone. Additionally, as shown in the appended Examples, a pharmaceutical formulation for use according to the invention provides significant pain relief with very low, if any, side effects like abuse potential and constipation compared to the use of opioids.Accordingly, the present invention is based on a surprising and unexpected effect since alpha-bisabolol and guaiol are known in the art to be associated with CBD as main cannabinoid rather than THC. Although the prior art describes various compositions comprising THC and terpenes (WO 2020 / 006599, WO 2020 / 006598, US 2021 / 204591 , and US 2018 / 352848), none of the prior art documents describes the specific constitution and the advantageous THC / terpene ratio disclosed in the present invention. This is further, because terpenes are suggested in the art to execute an enhancing effect on cannabinoids by means of an “inter-entourage effect” rather than vice versa. The Cannabis plant extract of the present invention comprises THC and the terpenes alpha- bisabolol and guaiol in the ratio as tested individually in the Examples (see Table 6). Thus, it is believed that a composition for use and pharmaceutical formulation for use of theinvention which has the same individual effective components and THC / terpene ratio as the Cannabis plant extract disclosed in the present Examples (Table 6), are particularly effective in providing cytotoxic activity, anti-inflammatory and analgesic activity. Further, the Examples provide evidence that the pharmaceutical formulation and the preferred composition of the invention have a superior technical effect of providing improved short- and long-term stability of cannabinoids such as THC by comprising a carrier oil such as sesame oil (Example 3). Additionally, the Examples provide evidence that a significant number of patients suffering from CNSLBP treated with a pharmaceutical formulation for use according to the present invention can achieve a clinically relevant pain reduction within the proposed dose range with very low abuse potential and low number of side effects compared to the use of opioids (see Fig. 4 and Tables 10-14). Indeed, the data reported from the ongoing clinical trial show that the 30% response rate and 50% response rate for patients suffering from CLBP treated with a pharmaceutical formulation for use according to the invention is on average 31 % and 26% higher, respectively, compared to previously reported response rates for treatment of CLBP with opioids. Furthermore, additional data reported from a second ongoing clinical trial show that patients have a reduced risk of developing constipation under treatment with the pharmaceutical formulation of the invention (the IMP) compared to an opioid therapy (see Table 15). Moreover, a higher number of patients achieved a significant pain reduction of at least 30%. The number of responders increased over the course of the study with 66% for the IMP compared to 56% for patients treated with opioids at the end of the treatment phase (see Table 16). Accordingly, the preliminary data renders plausible the use of a composition and / or pharmaceutical formulation according to the invention as the standard therapy in management of chronic pain, specifically chronic musculoskeletal pain, especially in pain management of CLBP, CNSLBP, osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles.In the following the invention is described in more detail.In particular the invention relates to the following items.

[0001] A composition for use in the treatment and / or prevention of chronic musculoskeletal pain, such as chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal painconditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol.[2] The composition for use of item 1 , wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in a ratio of between about 50:1 and 500:1 , preferably between about 100:1 and 450:1 , most preferably between about 160:1 and 295:1 in the composition.[3] The composition for use of item 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in a ratio of between about 10: 1 and 500: 1 , preferably between about 50:1 and 250:1 , most preferably between about 105:1 and 200:1 in the composition.[4] The composition for use of any one of items 1 to 3, wherein delta-9- tetrahydrocannabinol (THC) and beta-caryophyllene are present in a ratio of between about 10:1 and 500:1 , preferably between about 50:1 and 250:1 , most preferably between about 105:1 and 200:1 in the composition.[5] The composition for use of any one of items 1 to 4, wherein(a) delta-9-tetrahydrocannabinol (THC) and linalool are present in a ratio of between about 450:1 and 1400:1 , preferably between about 500:1 and 1330:1 in the composition;(b) THC and alpha-humulene are present in a ratio of between about 300: 1 and 725:1 , preferably between about 355:1 and 665:1 in the composition;(c) THC and nerolidol are present in a ratio of between about 200:1 and 600:1 , preferably between about 270:1 and 535:1 in the composition,(d) THC and caryophyllene oxide are present in a ratio of between about 1000:1 and 2150:1 , preferably between about 1090:1 and 2080:1 in the composition;(e) THC and alpha-pinene are present in a ratio of between about 5850:1 and 16000:1 , preferably between about 6000:1 and 15750:1 in the composition;(f) THC and camphene are present in a ratio of between about 7300:1 and 132950:1 , preferably between about 7300:1 and 132950:1 in the composition;(g) THC and beta-pinene are present in a ratio of between about 6475:1 and 23100:1 , preferably between about 6545:1 and 23025:1 in the composition;(h) THC and beta-myrcene are present in a ratio of between about 1950:1 and 6300:1 , preferably between about 2025:1 and 6210:1 in the composition;(i) THC and limonene are present in a ratio of between about 1650:1 and 5050:1 , preferably between about 1700:1 and 4970:1 in the composition;(j) THC and eucalyptol are present in a ratio of between about 5050:1 and 38650:1 , preferably between about 5140:1 and 38580:1 in the composition;(k) THC and ocimene are present in a ratio of between about 2500:1 and 44700:1 , preferably between about 2570:1 and 44610:1 in the composition;(l) THC and gamma-terpinene are present in a ratio of between about 4700:1 and 35750:1 , preferably between about 4800:1 and 35685:1 in the composition;(m) THC and terpinolene are present in a ratio of between about 5450:1 and 129850:1 , preferably between about 5535:1 and 129965:1 in the composition;(n) THC and alpha-terpinene are present in a ratio of between about 5150:1 and 58550:1 , preferably between about 5210:1 and 58480:1 in the composition;(o) THC and para-cymene are present in a ratio of between about 4700:1 and 56700:1 , preferably between about 4800:1 and 56625:1 in the composition;(p) THC isopulegol are present in a ratio of between about 4000:1 and 8000:1 , preferably between about 4060:1 and 7915:1 in the composition; and / or(q) THC and geraniol are present in a ratio of between about 1300:1 and 18250:1 , preferably between about 1375:1 and 18150:1 in the composition.[6] The composition for use of any one of items 1 to 5, wherein the composition comprises delta-9-tetrahydrocannabinol (THC) in an amount of between about 2.5 and 10 percent, preferably between about 4 and 6 percent, most preferably 5 percent by weight of the composition.[7] The composition for use of any one of items 1 to 6, wherein the composition comprises alpha-bisabolol in an amount of between about 0.008 and 0.065percent, preferably between about 0.01 and 0.04 percent, most preferably between about 0.017 and 0.031 percent by weight of the composition.[8] The composition for use of any one of items 1 to 7, wherein the composition comprises guaiol in an amount of between about 0.012 and 0.092 percent, preferably between about 0.015 and 0.05 percent, most preferably between about 0.025 and 0.046 percent by weight of the composition.[9] The composition for use of any one of items 1 to 8, wherein the composition comprises beta-caryophyllene in an amount of between about 0.012 and 0.094 percent, preferably between about 0.02 and 0.05 percent, most preferably between about 0.025 and 0.047 percent by weight of the composition.

[0010] The composition for use of any one of items 1 to 9, wherein the composition comprises(a) linalool in an amount of between about 0.001 and 0.014 percent, preferably between about 0.003 and 0.0085 percent, most preferably between about 0.004 and 0.007 percent by weight of the composition;(b) alpha-humulene in an amount of between about 0.003 and 0.028 percent, preferably between about 0.006 and 0.017 percent, most preferably between about 0.008 and 0.014 percent by weight of the composition;(c) nerolidol in an amount of between about 0.004 and 0.035 percent, preferably between about 0.007 and 0.021 percent, most preferably between about 0.009 and 0.017 percent by weight of the composition;(d) caryophyllene oxide in an amount of between about 0.001 and 0.0092 percent, preferably between about 0.001 and 0.0055 percent, most preferably between about 0.002 and 0.005 percent by weight of the composition; and / or(e) limonene in an amount of between about 0.0005 and 0.004 percent, preferably between about 0.0008 and 0.0022 percent, most preferably between about 0.001 and 0.002 percent by weight of the composition.

[0011] The composition for use of any one of items 1 to 10, wherein the composition is a Cannabis plant extract.

[0012] The composition for use of item 11 , wherein the Cannabis plant extract is obtainable by solvent extraction of a Cannabis plant.

[0013] The composition for use of item 11 or 12, wherein the Cannabis plant extract is obtainable by solvent extraction of flower material of the Cannabis plant, which has been preferably trimmed and dried before use.

[0014] The composition for use of item 12 or 13, wherein the Cannabis plant is DKJ127 (deposited by the Community Plant Variety Office with the application number A202104053).

[0015] The composition for use of any one of items 11 to 14, wherein the Cannabis plant extract is an alcoholic extract.

[0016] The composition for use of any one of items 1 to 15, wherein the composition is in liquid form.

[0017] The composition for use of any one of items 1 to 16, wherein the composition comprises a carrier oil, preferably sesame oil.

[0018] A pharmaceutical formulation for use in the treatment and / or prevention of chronic musculoskeletal pain, such as chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising the composition of any one of items 1 to 17.

[0019] The pharmaceutical formulation for use of item 18, wherein the formulation comprises delta-9-tetrahydrocannabinol (THC) in an amount of between about 1 .0 and 2.5 percent, preferably of 2.1 percent by weight of the formulation and wherein THC and alpha-bisabolol are present in a ratio of between about 100: 1 and 450: 1 , preferably between about 160:1 and 295:1 in the formulation, THC and guaiol are present in a ratio of between about 50:1 and 250:1 , preferably between about 105:1 and 200:1 in the formulation and / or THC and beta-caryophyllene are presentin a ratio of between about 50:1 and 250:1 , preferably between about 105:1 and 200:1 in the formulation.

[0020] The pharmaceutical formulation for use of item 19, wherein delta-9- tetrahydrocannabinol (THC) and linalool are present in a ratio of between about 450:1 and 1400:1 , preferably between about 500:1 and 1330:1 in the formulation, THC and alpha-humulene are present in a ratio of between about 300: 1 and 725: 1 , preferably between about 355:1 and 665:1 in the formulation, and THC and nerolidol are present in a ratio of between about 200:1 and 600:1 , preferably between about 270:1 and 535:1 in the formulation.

[0021] The pharmaceutical formulation for use of any one of items 18 to 20, wherein the formulation further comprises a carrier oil, preferably sesame oil.

[0022] A method for treatment and / or prevention of chronic musculoskeletal pain, such as chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles, the method comprising administering to a subject in need thereof an effective amount of the composition of any one of items 1 to 17, or of the pharmaceutical formulation of items 18 to 21 .

[0023] The composition for use of items 1 to 17, or the pharmaceutical formulation for use of items 18 to 21 , or the method of item 22, wherein the composition or the pharmaceutical formulation is administered via oral-, oromucosal-, intra-nasal-, topical-, rectal- or vaginal administration, but is preferably orally administered.

[0024] A kit for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising component A and component B, wherein component A is the composition for use of item 1 to 17, and component B is a carrier oil, preferably sesame oil.

[0025] The composition for use, the pharmaceutical formulation for use, the kit for use or the method of treatment of any one of the previous claims, wherein the chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles is selected from the group comprising back and neck pain, fibromyalgia, rheumatoid arthritis, psoriatic arthritis, gout, spondylarthritis, osteoporosis, osteopenia and sarcopenia.Accordingly, the invention relates to a composition for use as described in the above lists of items. Specifically, the present invention relates to a composition for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9- tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene, and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, paracymene, isopulegol and geraniol. The composition for use of the invention may comprise any amount of THC, any amount of alpha-bisabolol, any amount of guaiol, any amount of beta-caryophyllene, and any amount of at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alphapinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma- terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol in any suitable combination of contents, provided that the components are present in the composition for use of the invention. As such, the composition for use of the invention is considered to comprise a mixture of THC, alpha-bisabolol, guaiol and beta-caryophyllene, and at least one additional terpene selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha- terpinene, para-cymene, isopulegol and geraniol.The composition for use as described herein may comprise any suitable ratio of THC, alpha-bisabolol, guaiol and beta-caryophyllene, and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol,ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol.Suitable ratios present in the composition for use as described herein include THC / alpha- bisabolol ratios of between about 50: 1 , 60: 1 , 70: 1 , 80: 1 , 90: 1 , 100: 1 , 110:1, 120: 1 , 130: 1 , 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1,240:1,250:1,260:1, 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; for example between 75:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1 , 200:1 , 210:1 , 220:1 , 230:1 , 240:1 , 250:1 , 260:1 , 270:1 , 280:1 , 290:1 , 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1,420:1, 430:1, 440:1 and 450:1; or between 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1 , 200:1 , 210:1 , 220:1 , 230:1 , 240:1 , 250:1 , 260:1 , 270:1 , 280:1 , 290:1 , 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1,420:1, 430: 1 , 440: 1 , 450: 1 , 460: 1 , 470: 1 , 480: 1 , 490: 1 and 500: 1 ; or between 75: 1 , 80: 1 , 90: 1 , 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1, 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360:1, 370:1, 380:1, 390:1 and 400:1; or between 150:1, 160:1, 170:1, 180:1, 190:1, 200: 1,210:1, 220: 1 , 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1; or between 150:1, 160:1, 170:1, 180:1, 190:1 , 200:1 , 210:1 , 220:1 , 230:1 , 240:1 , 250:1 , 260:1 , 270:1 , 280:1 , 290:1 , 300: 1 , 310: 1 , 320: 1 , 330: 1 , 340: 1 and 350: 1 ; or alternatively, between 160: 1 , 170: 1180: 1 , 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1 and 295:1. In the context of the present invention, suitable ratios present in the composition for use as described herein include THC / alpha-bisabolol ratios of more than 50:1 , 60:1 , 70:1 , 80:1 , 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 185:1, 190:1, 200:1, 210: 1 , 220: 1 , 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1 , 310: 1 , 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400: 1,410:1, 420: 1 , 430: 1 , 440: 1 , 450: 1 , 460: 1 , 470:1, 480:1, 490:1, or 500:1. In the present invention, it is preferred thatTHC and alpha- bisabolol are present in the composition for use of the invention in a ratio of more than 160:1 , in a ratio of between 100:1 and 450:1 , even more preferably in a ratio of between 160:1 and 295:1.Suitable ratios present in the composition for use as described herein include THC / guaiol ratios of between about 10:1 , 20:1 , 30:1 , 40:1 , 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1,120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1,240:1, 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1 , 310: 1 , 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; for example between 30:1, 40:1, 50:1, 60:1, 70:1 , 80:1 , 90:1 , 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1,240:1,250:1, 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390:1, 400:1, 410:1, 420:1, 430:1, 440:1 and 450:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1 , 200:1 , 210:1 , 220: 1 , 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1, 230:1, 240:1 and 250:1; or, alternatively, between 105:1, 110:1, 115:1, 120:1, 125:1, 130:1, 135:1, 140:1, 145:1, 150:1, 155:1, 160:1, 165:1, 170:1, 175:1, 180:1, 185:1, 190:1, 195:1 and 200:1. In the context of the present invention, suitable ratios present in the composition for use as described herein include THC / guaiol ratios of more than 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 105:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1,240:1,250:1,260:1,270:1, 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400: 1 , 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, or 500:1. In the present invention, it is preferred that THC and guaiol are present in the composition for use of the invention in a ratio of more than 105:1, in a ratio of between 50:1 and 250:1, even more preferably in a ratio of between 105:1 and 200:1.Suitable ratios present in the composition for use as described herein include THC / beta- caryophyllene ratios of between about 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1, 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400: 1,410:1, 420: 1 , 430: 1 , 440: 1 , 450: 1 , 460: 1 , 470: 1 , 480: 1 , 490:1 and 500:1; for example between 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1, 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400: 1,410:1, 420: 1 , 430: 1 , 440: 1 and 450: 1 ; or between 50: 1 , 60: 1 , 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200: 1,210:1, 220: 1 , 230: 1 , 240: 1 , 250: 1 , 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 and 400: 1 ; or between 50: 1 , 60: 1 , 70: 1 ,80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210: 1 , 220: 1 , 230: 1 , 240: 1 and 250: 1 ; or alternatively between 105: 1 , 110: 1 , 115: 1 , 120: 1 , 125:1, 130:1, 135:1, 140:1, 145:1, 150:1, 155:1, 160:1, 165:1, 170:1, 175:1, 180:1, 185:1, 190:1, 195:1 and 200:1. In the context of the present invention, suitable ratios present in the composition for use as described herein include THC / beta-caryophyllene ratios of more than 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 105:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1,200:1,210:1,220:1,230:1,240:1,250:1, 260: 1 , 270: 1 , 280: 1 , 290: 1 , 300: 1,310:1, 320: 1 , 330: 1 , 340: 1 , 350: 1 , 360: 1 , 370: 1 , 380: 1 , 390: 1 , 400: 1 , 410: 1 , 420: 1 , 430: 1 , 440: 1 , 450: 1 , 460: 1 , 470: 1 , 480: 1 , 490: 1 or 500: 1. In the present invention, it is preferred that THC and beta-caryophyllene are present in the composition for use of the invention in a ratio of more than 105:1, in a ratio of between 50:1 and 250:1, even more preferably in a ratio of between 105:1 and 200:1.Suitable ratios present in the composition for use as described herein include a THC / linalool ratio of between 450:1 and 1400:1, a THC / alpha-humulene ratio of between 300:1 and 725:1 , a THC / nerolidol ratio of between 200:1 and 600:1 , a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1, a THC / alpha-pinene ratio of between 5850:1 and 16000:1, a THC / camphene ratio of between 7300:1 and 132950:1, a THC / beta- pinene ratio of between 6475:1 and 23100:1, a THC / beta-myrcene ratio of between 1950:1 and 6300:1, a THC / limonene ratio of between 1650:1 and 5050:1, a THC / eucalyptol ratio of between 5050:1 and 38650:1, a THC / ocimene ratio of between 2500:1 and 44700:1, a THC / gamma-terpinene ratio of between 4700:1 and 35750:1, a THC / terpinolene ratio of between 5450:1 and 129850:1, a THC / alpha-terpinene ratio of between 5150:1 and 58550:1, a THC / para-cymene ratio of between 4700:1 and 56700:1, a THC / isopulegol ratio of between 4000:1 and 8000:1, and a THC / geraniol ratio of between 1300:1 and 18250:1. Preferred ratios present in the composition for use as described herein include a THC / linalool ratio of between 500: 1 and 1330: 1 , a THC / alpha- humulene ratio of between 355: 1 and 665: 1 , a THC / nerolidol ratio of between 270: 1 and 535:1, a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1, a THC / alpha- pinene ratio of between 6000:1 and 15750:1, a THC / camphene ratio of between 7300:1 and 132950:1, a THC / beta-pinene ratio of between 6545:1 and 23025:1, a THC / beta- myrcene ratio of between 2025:1 and 6210:1, a THC / limonene ratio of between 1700:1 and 4970:1, a THC / eucalyptol ratio of between 5140:1 and 38580:1, a THC / ocimene ratio of between 2570:1 and 44610:1, a THC / gamma-terpinene ratio of between 4800:1 and 35685: 1 , a THC / terpinolene ratio of 5535: 1 and 129965: 1 , a THC / alpha-terpinene ratio ofbetween 5210:1 and 58480:1 , a THC / para-cymene ratio of between 4800:1 and 56625:1 , a THC / isopulegol ratio of between 4060:1 and 7915:1 and a THC / geraniol ratio of between 1375:1 and 18150:1.Accordingly, in the present invention, it is preferred that THC and alpha-bisabolol are present in the composition for use of the invention in a ratio of between 100: 1 and 450: 1 , THC and guaiol are present in the composition for use of the invention in a ratio of between 50:1 and 250:1 , THC and beta-caryophyllene are present in the composition for use of the invention in a ratio of between 50:1 and 250:1 , and the composition for use of the invention further comprises at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 450:1 and 1400:1 , alpha-humulene in a THC / alpha-humulene ratio of between 300:1 and 725:1 , nerolidol in a THC / nerolidol ratio of between 200: 1 and 600: 1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , alpha-pinene in a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , camphene in a THC / camphene ratio of between 7300:1 and 132950:1 , beta-pinene in a THC / beta-pinene ratio of between 6475:1 and 23100:1 , betamyrcene in a THC / beta-myrcene ratio of between 1950:1 and 6300:1 , limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , eucalyptol in a THC / eucalyptol ratio of between 5050:1 and 38650:1 , ocimene in a THC / ocimene ratio of between 2500:1 and 44700:1 , gamma-terpinene a THC / gamma-terpinene ratio of between 4700:1 and 35750:1 , terpinolene in a THC / terpinolene ratio of between 5450:1 and 129850:1 , alphaterpinene in a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , para-cymene in a THC / para-cymene ratio of between 4700:1 and 56700:1 , isopulegol in a THC / isopulegol ratio of between 4000:1 and 8000:1 and geraniol in a THC / geraniol ratio of between 1300:1 and 18250:1. In the present invention, it is even more preferred that THC and alpha-bisabolol are present in the composition for use of the invention in a ratio of between 160:1 and 295:1 , THC and guaiol are present in the composition for use of the invention in a ratio of between 105:1 and 200:1 , and THC and beta-caryophyllene are present in the composition for use of the invention in a ratio of between 105: 1 and 200: 1 , and the composition for use of the invention further comprises at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 500: 1 and 1330: 1 , alpha-humulene in a THC / alpha-humulene ratio of between 355: 1 and 665: 1 , nerolidol in a THC / nerolidol ratio of between 270: 1 and 535: 1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1 , alpha-pinene in a THC / alpha-pinene ratio of between 6000:1 and 15750:1 , camphene in a THC / campheneratio of between 7300:1 and 132950:1 , beta-pinene in a THC / beta-pinene ratio of between 6545:1 and 23025:1 , beta-myrcene in a THC / beta-myrcene ratio of between 2025:1 and 6210:1 , limonene in a THC / limonene ratio of between 1700:1 and 4970:1 , eucalyptol in a THC / eucalyptol ratio of between 5140:1 and 38580:1 , ocimene in a THC / ocimene ratio of between 2570: 1 and 44610: 1 , gamma-terpinene in a THC / gamma- terpinene ratio of between 4800:1 and 35685:1 , terpinolene in a THC / terpinolene ratio of 5535:1 and 129965:1 , alpha-terpinene in a THC / alpha-terpinene ratio of between 5210:1 and 58480:1 , para-cymene in a THC / para-cymene ratio of between 4800:1 and 56625:1 , isopulegol in a THC / isopulegol ratio of between 4060:1 and 7915:1 , and geraniol in a THC / geraniol ratio of between 1375:1 and 18150:1.In the context of the present invention the term “at least one additional terpene selected from the group consisting of” means that at least 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, or 17 additional terpene(s) selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha- terpinene, para-cymene, isopulegol and geraniol is(are) present in the composition for use described herein, i.e. the composition for use of the invention which comprises THC, alpha-bisabolol, guaiol and beta-caryophyllene. Exemplarily, in the context of the present invention, the composition for use of the present invention comprises preferably at least 1 , 2, 3, 4, or 5 terpene(s) selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide and limonene.The composition for use of the invention may comprise at least about 2.5%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15% or 20% THC by weight of the composition; for example between about 2.5%, 3%, 4%, 5%, 6%, 7%, 8%, 9% and 10% THC by weight of the composition; or between 2.5%, 3%, 4%, 5%, 6%, 7% and 8%; or between 3%, 4%, 5%, 6% and 7%; or between 3%, 4%, 5% and 6%; or between 4%, 5% and 6% THC by weight of the composition. The skilled person is aware that the above values given in % by weight may also be provided in parts per million (ppm), e.g. mg / kg or mg / l. It is preferred that the composition for use of the invention comprises THC in an amount of between about 2.5% and 10%, of at least about 4%, or preferably of between about 4% and 6% by weight of the composition. In the present invention, the composition for use of the invention comprises THC most preferably in an amount of 5% by weight of the composition. As amatter of example, an amount of 5% THC by weight of the composition would convert to 50,000 ppm.In the context of the present invention, the composition for use of the invention may also comprise at least about 0.001 %, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01 %, 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% alpha-bisabolol by weight of the composition; for example between about 0.005%, 0.008%, 0.01 %, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06% and 0.065%; or between 0.001 %, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01 %, 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% and 0.04%; or, alternatively, between 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01 %, 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029% and 0.03%; or between 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029% and 0.03%; or alternatively between 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026% and 0.027% alpha-bisabolol by weight of the composition. The composition for use of the invention may comprise alpha-bisabolol in an amount of between 0.008% and 0.065%, preferably between 0.01 % and 0.04% by weight of the composition. Even more preferably, the composition for use of the invention comprises alpha-bisabolol in an amount of at least 0.017% by weight of the composition, or most preferably between 0.017% and 0.031 % by weight of the composition.As such, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% and alpha-bisabolol in an amount of between about 0.008% and 0.065% by weight of the composition. More preferably, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% by weight of the composition and alpha-bisabolol in an amount of between about 0.01 % and 0.04% by weight of the composition. Accordingly, the composition for use of the inventionmay comprise THC in an amount of between about 2.5% and 10%, of at least 4%, preferably between 4% and 6% by weight of the composition and alpha-bisabolol in an amount of at least 0.008% by weight of the composition, between about 0.008% and 0.065% by weight of the composition, preferably between about 0.01 % and 0.04% by weight of the composition.Most preferably, the composition for use as described herein comprises THC in an amount of 5% by weight of the composition and alpha-bisabolol in an amount of between about 0.017% and 0.031 % by weight of the composition. In the context of the present invention, the composition for use as described herein may comprise THC in an amount of 5% by weight of the composition and alpha-bisabolol in an amount of at least about 0.017% by weight of the composition.In the present invention, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% THC by weight of the composition and a THC / alpha-bisabolol ratio of between 100:1 and 450:1. Moreover, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.008% and 0.065% by weight of the composition and a THC / alpha-bisabolol ratio of between 100:1 and 450:1.More preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% THC by weight of the composition and a THC / alpha-bisabolol ratio of between 100:1 and 450:1. Moreover, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.01 % and 0.04% by weight of the composition and a THC / alpha-bisabolol ratio of between 100:1 and 450:1.Most preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of 5% THC by weight of the composition and a THC / alpha- bisabolol ratio of between 160:1 and 295:1. Further, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.014% and 0.031 % by weight of the composition and a THC / alpha-bisabolol ratio of between 160:1 and 295:1.In the present invention, the composition for use of the invention may also comprise THC in an amount of 5% by weight of the composition and a THC / alpha-bisabolol ratio of at least about 160:1 . In the present invention, the composition for use of the invention may also comprise alpha-bisabolol in an amount of at least 0.01 % by weight of thecomposition, preferably between about 0.01 % and 0.04% by weight of the composition and an alpha-bisabolol / THC ratio of more than 1 :100.In the context of the present invention, the composition for use of the invention may also comprise at least about 0.001 %, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01 %, 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% guaiol by weight of the composition; for example between about 0.012%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075%, 0.08%, 0.085%, 0.09% and 0.092%; or between 0.001 %, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.004%, 0.0045%, 0.005%, 0.0055%, 0.006%, 0.0065%, 0.007%, 0.0075%, 0.008%, 0.0085%, 0.009%, 0.0095%, 0.01 %, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075% and 0.08%; or between 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.020%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.04%, 0.041 %, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049% and 0.05%; or, alternatively, between 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.040%, 0.041 %, 0.042%, 0.043%, 0.044%, 0.045% and 0.046% guaiol by weight of the composition. The composition for use of the invention may comprise guaiol in an amount of between 0.012% and 0.092%, preferably between 0.015% and 0.05% by weight of the composition. Even more preferably, the composition for use of the invention comprises guaiol in an amount of at least 0.025% by weight of the composition, or most preferably between 0.025% and 0.046% by weight of the composition.As such, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% and guaiol in an amount of between about 0.012% and 0.092% by weight of the composition. More preferably, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% by weight of the composition and guaiol in an amount of between about 0.015% and 0.05% by weight of the composition. Accordingly, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10%, of at least 4%, preferably between 4% and 6% by weight of the composition and guaiol in an amount of at least 0.012% by weightof the composition, between about 0.012% and 0.092% by weight of the composition, preferably between about 0.015% and 0.05% by weight of the composition. Most preferably, the composition for use as described herein comprises THC in an amount of 5% by weight of the composition and guaiol in an amount of between about 0.025% and 0.046% by weight of the composition. In the context of the present invention, the composition for use as described herein may comprise THC in an amount of 5% by weight of the composition and guaiol in an amount of at least about 0.025% by weight of the composition.In the present invention, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% THC by weight of the composition and a THC / guaiol ratio of between 50:1 and 250:1. Moreover, in the context of the present invention, the composition for use of the invention may comprise guaiol in an amount of between about 0.012% and 0.092% by weight of the composition and a THC / guaiol ratio of between 50: 1 and 250: 1 .More preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% THC by weight of the composition and a THC / guaiol ratio of between 50: 1 and 250:1 . Moreover, in the context of the present invention, the composition for use of the invention may comprise guaiol in an amount of between about 0.015% and 0.05% by weight of the composition and a THC / guaiol ratio of between 50:1 and 250:1.Most preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of 5% THC by weight of the composition and a THC / guaiol ratio of between 105:1 and 200:1. Further, in the context of the present invention, the composition for use of the invention may comprise guaiol in an amount of between about 0.025% and 0.046% by weight of the composition and a THC / guaiol ratio of between 105:1 and 200:1.In the present invention, the composition for use of the invention may also comprise THC in an amount of 5% by weight of the composition and a THC / guaiol ratio of at least about 105:1. In the present invention, the composition for use of the invention may also comprise guaiol in an amount of at least 0.015% by weight of the composition, preferably between about 0.015% and 0.05% by weight of the composition and an guaiol / THC ratio of more than 1 :50.In the context of the present invention, the composition for use of the invention may also comprise at least about 0.001 %, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01 %, 0.011 %, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% beta-caryophyllene by weight of the composition; for example between about 0.012%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075%, 0.08%, 0.085%, 0.09% and 0.094%; or between 0.001 %, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.004%, 0.0045%, 0.005%, 0.0055%, 0.006%, 0.0065%, 0.007%, 0.0075%, 0.008%, 0.0085%, 0.009%, 0.0095%, 0.01 %, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075% and 0.08%; or between 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.020%, 0.021 %, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.04%, 0.041 %, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049% and 0.05%; or between 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031 %, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.040%, 0.041 %, 0.042%, 0.043%, 0.044%, 0.045%, 0.046% and 0.047% betacaryophyllene by weight of the composition. The composition for use of the invention may comprise beta-caryophyllene in an amount of between 0.0012% and 0.094%, preferably between 0.02% and 0.05% by weight of the composition. Even more preferably, the composition for use of the invention comprises beta-caryophyllene in an amount of at least 0.025% by weight of the composition, or most preferably between 0.025% and 0.047% by weight of the composition.As such, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% and beta-caryophyllene in an amount of between about 0.012% and 0.094% by weight of the composition. More preferably, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% by weight of the composition and beta-caryophyllene in an amount of between about 0.02% and 0.05% by weight of the composition. Accordingly, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10%, of at least 4%, preferably between 4% and 6% by weight of the composition and beta-caryophyllene in an amount of at least 0.012% by weight of the composition, between about 0.012%and 0.094% by weight of the composition, preferably between about 0.02% and 0.05% by weight of the composition.Most preferably, the composition for use as described herein comprises THC in an amount of 5% by weight of the composition and beta-caryophyllene in an amount of between about 0.025% and 0.047% by weight of the composition. In the context of the present invention, the composition for use as described herein may comprise THC in an amount of 5% by weight of the composition and beta-caryophyllene in an amount of at least about 0.025% by weight of the composition.In the present invention, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% THC by weight of the composition and a THC / beta-caryophyllene ratio of between 50:1 and 250:1. Moreover, in the context of the present invention, the composition for use of the invention may comprise betacaryophyllene in an amount of between about 0.012% and 0.094% by weight of the composition and a THC / beta-caryophyllene ratio of between 50:1 and 250:1.More preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% THC by weight of the composition and a THC / beta-caryophyllene ratio of between 50:1 and 250:1. Moreover, in the context of the present invention, the composition for use of the invention may comprise beta-caryophyllene in an amount of between about 0.02% and 0.05% by weight of the composition and a THC / beta-caryophyllene ratio of between 50:1 and 250:1.Most preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of 5% THC by weight of the composition and a THC / beta- caryophyllene ratio of between 105:1 and 200:1. Further, in the context of the present invention, the composition for use of the invention may comprise beta-caryophyllene in an amount of between about 0.025% and 0.047% by weight of the composition and a THC / beta-caryophyllene ratio of between 105:1 and 200:1.In the present invention, the composition for use of the invention may also comprise THC in an amount of 5% by weight of the composition and a THC / beta-caryophyllene ratio of at least about 105:1. In the present invention, the composition for use of the invention may also comprise beta-caryophyllene in an amount of at least 0.025% by weight of the composition, preferably between about 0.02% and 0.05% by weight of the composition and an beta-caryophyllene / THC ratio of more than 1 :50.The composition for use of the invention further comprises at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. In the present invention, the composition for use of the invention may comprise linalool in an amount of between 0.001 % and 0.014% by weight of the composition, alpha- humulene in an amount of between 0.003% and 0.028% by weight of the composition, nerolidol in an amount of between 0.004% and 0.035% by weight of the composition, caryophyllene oxide in an amount of between 0.001 % and 0.0092% by weight of the composition, alpha-pinene in an amount of between 0.0001 % and 0.002% by weight of the composition, camphene in an amount of between 0.00001 % and 0.0015% by weight of the composition, beta-pinene in an amount of between 0.0001 % and 0.0015% by weight of the composition, beta-myrcene in an amount of between 0.0004% and 0.005% by weight of the composition, limonene in an amount of between 0.0005% and 0.004% by weight of the composition, eucalyptol in an amount of between 0.00006% and 0.002% by weight of the composition, ocimene in an amount of between 0.00005% and 0.004% by weight of the composition, gamma-terpinene in an amount of between 0.00007% and 0.002% by weight of the composition, terpinolene in an amount of between 0.00002% and 0.002% by weight of the composition, alpha-terpinene in an amount of between 0.00004% and 0.002% by weight of the composition, para-cymene in an amount of between 0.00004% and 0.002%, isopulegol in an amount of between 0.0003% and 0.003% by weight of the composition, and / or geraniol in an amount of between 0.0001 % and 0.008% by weight of the composition.Preferably, the composition for use of the invention may comprise linalool in an amount of between 0.003% and 0.0085% by weight of the composition, alpha-humulene in an amount of between 0.006% and 0.017% by weight of the composition, nerolidol in an amount of between 0.007% and 0.021 % by weight of the composition, caryophyllene oxide in an amount of between 0.001 % and 0.0055% by weight of the composition, alphapinene in an amount of between 0.0002% and 0.001 % by weight of the composition, camphene in an amount of between 0.00003% and 0.00082% by weight of the composition, beta-pinene in an amount of between 0.0001 % and 0.00092% by weight of the composition, beta-myrcene in an amount of between 0.0004% and 0.005% by weight of the composition, limonene in an amount of between 0.0008% and 0.0022% by weight of the composition, eucalyptol in an amount of between 0.0001 % and 0.0012% by weightof the composition, ocimene in an amount of between 0.00009% and 0.0023% by weight of the composition, gamma-terpinene in an amount of between 0.0001 % and 0.0013% by weight of the composition, terpinolene in an amount of between 0.00003% and 0.001 % by weight of the composition, alpha-terpinene in an amount of between 0.00006% and 0.0012% by weight of the composition, para-cymene in an amount of between 0.00007% and 0.0013% by weight of the composition, isopulegol in an amount of between 0.0005% and 0.0015% by weight of the composition, and / or geraniol in an amount of between 0.0002% and 0.0044% by weight of the composition.In the present invention, the composition for use of the invention may comprise THC in an amount of between about 2.5% and 10% THC by weight of the composition, a THC / alpha-bisabolol ratio of between 100:1 and 450:1 , a THC / guaiol ratio of between 50:1 and 250:1 , a THC / beta-caryophyllene ratio of between 50:1 and 250:1 and further comprises at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 650:1 and 1400:1 , alpha-humulene in a THC / alpha- humulene ratio of between 300:1 and 725:1 , nerolidol in a THC / nerolidol ratio of between 200:1 and 600:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , alpha-pinene in a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , camphene in a TH C / cam phene ratio of between 7300:1 and 132950:1 , betapinene in a THC / beta-pinene ratio of between 6475:1 and 23100:1 , beta-myrcene in a THC / beta-myrcene ratio of between 1950:1 and 6300:1 , limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , eucalyptol in a THC / eucalyptol ratio of between 5050:1 and 38650:1 , ocimene in a THC / ocimene ratio of between 2500:1 and 44700:1 , gamma-terpinene a THC / gamma-terpinene ratio of between 4700:1 and 35750:1 , terpinolene in a THC / terpinolene ratio of between 5450:1 and 129850:1 , alpha-terpinene in a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , para-cymene in a THC / para-cymene ratio of between 4700:1 and 56700:1 , isopulegol in a THC / isopulegol ratio of between 4000:1 and 8000:1 , and geraniol in a THC / geraniol ratio of between 1300:1 and 18250:1.Moreover, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.008% and 0.065% by weight of the composition, guaiol in an amount of between about 0.012% and 0.092% by weight of the composition, beta-caryophyllene in an amount of between about 0.012% and 0.094% by weight of the composition, and at least one additional terpene selected from the group consisting of linalool in an amount of between 0.001 % and 0.014%, alpha-humulene in an amount of between 0.003% and 0.028%, nerolidol in an amount of between 0.004% and 0.035%, caryophyllene oxide in an amount of between 0.001 % and 0.0092%, alpha-pinene in an amount of between 0.0001 % and 0.002%, camphene in an amount of between 0.00001 % and 0.0015%, beta-pinene in an amount of between 0.0001 % and 0.0015%, beta-myrcene in an amount of between 0.0004% and 0.005%, limonene in an amount of between 0.0005% and 0.004%, eucalyptol in an amount of between 0.00006% and 0.002%, ocimene in an amount of between 0.00005% and 0.004%, gamma-terpinene in an amount of between 0.00007% and 0.002%, terpinolene in an amount of between 0.00002% and 0.002%, alpha-terpinene in an amount of between 0.00004% and 0.002%, para-cymene in an amount of between 0.00004% and 0.002%, isopulegol in an amount of between 0.0003% and 0.003%, and geraniol in an amount of between 0.0001 % and 0.008% by weight of the composition, a THC / alpha- bisabolol ratio of between 100:1 and 450:1 , and further comprises a THC / guaiol ratio of between 50: 1 and 250: 1 , and a THC / beta-caryophyllene ratio of between 50: 1 and 250: 1 , and at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 450:1 and 1400:1 , alpha-humulene in a THC / alpha- humulene ratio of between 300:1 and 725:1 , nerolidol in a THC / nerolidol ratio of between 200:1 and 600:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , alpha-pinene in a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , camphene in a TH C / cam phene ratio of between 7300:1 and 132950:1 , betapinene in a THC / beta-pinene ratio of between 6475:1 and 23100:1 , beta-myrcene in a THC / beta-myrcene ratio of between 1950:1 and 6300:1 , limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , eucalyptol in a THC / eucalyptol ratio of between 5050:1 and 38650:1 , ocimene in a THC / ocimene ratio of between 2500:1 and 44700:1 , gamma-terpinene a THC / gamma-terpinene ratio of between 4700:1 and 35750:1 , terpinolene in a THC / terpinolene ratio of between 5450:1 and 129850:1 , alpha-terpinene in a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , para-cymene in a THC / para-cymene ratio of between 4700:1 and 56700:1 , isopulegol in a THC / isopulegol ratio of between 4000:1 and 8000:1 and geraniol in a THC / geraniol ratio of between 1300:1 and 18250:1.More preferably, in the present invention, the composition for use of the invention may comprise THC in an amount of between about 4% and 6% THC by weight of the composition, a THC / alpha-bisabolol ratio of between 100:1 and 450:1 , a THC / guaiol ratio of between 50:1 and 250:1 , and a THC / beta-caryophyllene ratio of between 50:1 and250:1 and at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 450:1 and 1400:1 , alpha-humulene in a THC / alpha- humulene ratio of between 300:1 and 725:1 , nerolidol in a THC / nerolidol ratio of between 200:1 and 600:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , alpha-pinene in a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , camphene in a TH C / cam phene ratio of between 7300:1 and 132950:1 , betapinene in a THC / beta-pinene ratio of between 6475:1 and 23100:1 , beta-myrcene in a THC / beta-myrcene ratio of between 1950:1 and 6300:1 , limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , eucalyptol in a THC / eucalyptol ratio of between 5050:1 and 38650:1 , ocimene in a THC / ocimene ratio of between 2500:1 and 44700:1 , gamma-terpinene a THC / gamma-terpinene ratio of between 4700:1 and 35750:1 , terpinolene in a THC / terpinolene ratio of between 5450:1 and 129850:1 , alpha-terpinene in a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , para-cymene in a THC / para-cymene ratio of between 4700:1 and 56700:1 , isopulegol in a THC / isopulegol ratio of between 4000:1 and 8000:1 and geraniol in a THC / geraniol ratio of between 1300:1 and 18250:1.Moreover, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.01 % and 0.04% by weight of the composition, guaiol in an amount of between about 0.015% and 0.05% by weight of the composition, beta-caryophyllene in an amount of between about 0.02% and 0.05% by weight of the composition, and at least one additional terpene selected from the group consisting of linalool in an amount of between 0.003% and 0.0085% by weight of the composition, alpha-humulene in an amount of between 0.006% and 0.017% by weight of the composition, nerolidol in an amount of between 0.007% and 0.021 % by weight of the composition, caryophyllene oxide in an amount of between 0.001 % and 0.0055% by weight of the composition, alpha-pinene in an amount of between 0.0002% and 0.001 % by weight of the composition, camphene in an amount of between 0.00003% and 0.00082% by weight of the composition, beta-pinene in an amount of between 0.0001 % and 0.00092% by weight of the composition, beta-myrcene in an amount of between 0.0004% and 0.005% by weight of the composition, limonene in an amount of between 0.0008% and 0.0022% by weight of the composition, eucalyptol in an amount of between 0.0001 % and 0.0012% by weight of the composition, ocimene in an amount of between 0.00009% and 0.0023% by weight of the composition, gamma-terpinene in an amount of between 0.0001 % and 0.0013% by weight of the composition, terpinolene inan amount of between 0.00003% and 0.001 % by weight of the composition, alphaterpinene in an amount of between 0.00006% and 0.0012% by weight of the composition, para-cymene in an amount of between 0.00007% and 0.0013% by weight of the composition, isopulegol in an amount of between 0.0005% and 0.0015% by weight of the composition, and geraniol in an amount of between 0.0002% and 0.0044% by weight of the composition, and further comprises a THC / alpha-bisabolol ratio of between 100: 1 and 450: 1 , a THC / guaiol ratio of between 50: 1 and 250: 1 , and a THC / beta-caryophyllene ratio of between 50:1 and 250:1 and at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 450:1 and 1400:1 , alpha-humulene in a THC / alpha-humulene ratio of between 300:1 and 725:1 , nerolidol in a THC / nerolidol ratio of between 200: 1 and 600: 1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , alpha-pinene in a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , camphene in a THC / camphene ratio of between 7300:1 and 132950:1 , beta-pinene in a THC / beta-pinene ratio of between 6475:1 and 23100:1 , betamyrcene in a THC / beta-myrcene ratio of between 1950:1 and 6300:1 , limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , eucalyptol in a THC / eucalyptol ratio of between 5050:1 and 38650:1 , ocimene in a THC / ocimene ratio of between 2500:1 and 44700:1 , gamma-terpinene a THC / gamma-terpinene ratio of between 4700:1 and 35750:1 , terpinolene in a THC / terpinolene ratio of between 5450:1 and 129850:1 , alphaterpinene in a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , para-cymene in a THC / para-cymene ratio of between 4700:1 and 56700:1 , isopulegol in a THC / isopulegol ratio of between 4000:1 and 8000:1 and geraniol in a THC / geraniol ratio of between 1300:1 and 18250:1.The skilled person will appreciate that certain terpenes selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol are present in the composition for use of the invention but may become non-detectable because their concentration may be below the identification threshold or detection limit. Accordingly, in the present invention, the composition for use of the invention may comprise THC in an amount of 5% THC and at least one of group of linalool in an amount of 0.003% and 0.0085%, most preferably 0.004% and 0.007% by weight of the composition, alpha- humulene in an amount of between 0.006% and 0.017%, most preferably 0.008 and 0.014 percent by weight of the composition, nerolidol in an amount of between 0.007% and0.021 %, most preferably 0.009% and 0.017% by weight of the composition, caryophyllene oxide in an amount of between 0.001 % and 0.0055%, most preferably 0.002% and 0.005% by weight of the composition, and limonene in an amount of between 0.0008% and 0.0022%, most preferably 0.001 % and 0.002% by weight of the composition. The composition for use of the invention may also comprise THC in an amount of 5% THC by weight of the composition, a THC / alpha-bisabolol ratio of between 160:1 and 295:1 , a THC / guaiol ratio of between 105:1 and 200:1 and a THC / beta- caryophyllene ratio of between 105: 1 and 200:1 and further comprises at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 500: 1 and 1330:1 , alpha-humulene in a THC / alpha-humulene ratio of between 355:1 and 665:1 , nerolidol in a THC / nerolidol ratio of between 270:1 and 535:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1 and limonene in a THC / limonene ratio of between 1700:1 and 4970:1.Further, in the context of the present invention, the composition for use of the invention may comprise alpha-bisabolol in an amount of between about 0.017% and 0.031 % by weight of the composition, guaiol in an amount of between about 0.025% and 0.046% by weight of the composition, beta-caryophyllene in an amount of between about 0.025% and 0.047% by weight of the composition, at least one additional terpene selected from the group consisting of linalool in an amount of between 0.004% and 0.007% by weight of the composition, alpha-humulene in an amount of between 0.008% and 0.014% by weight of the composition, nerolidol in an amount of between 0.009% and 0.017% by weight of the composition, caryophyllene oxide in an amount of between 0.002% and 0.005% by weight of the composition, and limonene in an amount of between 0.001 % and 0.002% by weight of the composition, and may further comprise a THC / alpha- bisabolol ratio of between 160:1 and 295:1 , a THC / guaiol ratio of between 105:1 and 200:1 and a THC / beta-caryophyllene ratio of between 105:1 and 200:1 and further comprises at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 500:1 and 1330:1 , alpha-humulene in a THC / alpha- humulene ratio of between 355:1 and 665:1 , nerolidol in a THC / nerolidol ratio of between 270:1 and 535:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1 , and limonene in a THC / limonene ratio of between 1700:1 and 4970:1 .In the present invention, it is most preferred that the composition for use of the invention comprises the components set out in Table 1 below.Table 1: Preferred amounts of components comprised in the composition of the inventionSuitable methods to qualitatively and quantitatively determine, analyze, control or set the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene and / or terpenes selected from the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gammaterpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol are known in the art and include Thin Layer Chromatography (TLC) or High-Performance Liquid Chromatography (HPLC) (Eingestellter Cannab / s-Extrakt (Cannabis extractum normatum), Deutsches Arzneibuch (DAB) 2021 , ISBN: 978-3-7692-7804-0) and gas chromatography (GC) with detection by mass spectrometer (Ferrer I. and Thurman M.E., Elsevier 2020. ISBN: 978-0-4446-4341-4; Opie S.R., Springer Nature 2021. ISBN: 978- 3-030-62715-7).The composition for use of the invention may be any suitable composition, provided that it comprises a combination of the substances / components THC, alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The composition for use of the invention is preferably in liquid form. In the context of the present invention, the composition for use of the invention may also be provided in solid, e.g. powder, form to be subjected to reconstitution into liquid form, thereby providing the composition for use of the invention. The composition for use of the invention may be an aqueous solution or a non-aqueous solution such as an alcoholic solution, or a mixture of both in a suitable ratio. The composition for use of the invention may be produced from a precursor material naturally comprising THC or its prodrug THCA, alpha-bisabolol, guaiol, beta-caryophyllene or terpene(s) selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alphaterpinene, para-cymene, isopulegol and geraniol. It is evident for the skilled person that THC content as used herein may also refer to THC equivalents which is the sum of THC and THCA*0.877. Accordingly, in the context of the present invention, the "THC content" may refer to the sum of THC and THCA. THC and THCA may be determined and quantified by methods known in the art, e.g. by using liquid chromatography with addition of respective THC and THCA reference standards (Deutsches Arzneibuch (DAB) 2018, ISBN: 978-3-7692-7217-8), and Danish Medicines Standards 2020.0, BEK Nr. 1231 af.)In the context of the present invention, it should be understood that THC as used in the present invention may also be initially present in its carboxylated form THCA to be decarboxylated to the active THC comprised in the composition for use of the invention. In the present invention, decarboxylation of THCA to THC (equivalent to other cannabinoids) may be performed by any suitable method known in the art. Preferably, decarboxylation, of e.g. a Cannabis plant extract, is conducted via thermally induced decarboxylation under vacuum (in vacuo). Therefore, a rotary evaporator is used by adjusting water bath temperature, pressure, and rotation to 80°C, 185 mbar and 150 rpm, respectively. A suitable decarboxylation time amounts to 72 h. One non-limiting example of a precursor material to produce the composition for use of the invention may be an extract naturally comprising THC(A), alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alphaterpinene, para-cymene, isopulegol and geraniol e.g. the extract as described herein. In the context of the present invention, THC, alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alphaterpinene, para-cymene, isopulegol and geraniol may have been artificially added / combined to be comprised in the composition for use of the invention. In case THC, alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol,ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol may be artificially added / combined to be comprised in the composition for use of the invention, the pure substances THC (or THCA to be subjected to decarboxylation as described above), alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol or suitable precursor substances may be commercially obtained. As explained in the Example section, THC (e.g. naturally produced or isolated, or synthetically produced dronabinol) may be obtained from commercial suppliers such as LGC Standards, Smolecule, Benchchem or Cerilliant, and alpha-bisabolol, guaiol, betacaryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, betapinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol may be obtained from commercial suppliers such as Sigma-Aldrich, Biomol / Cayman, LGC Standards, Alfa Chemistry, Molport or Restek, respectively. They may also be isolated, chemically synthesized by means known in the art or heterologously produced in a suitable cell or organism. For example, THC as used in the composition of the invention or its prodrug THCA may be produced via heterologous cannabinoid production in a biosynthetic process as e.g. reported in the literature (e.g. Lou et al., Nature 2019, 567: 123-126). The skilled person knows suitable methods for recovering and purifying recombinant products. For example, THC may be isolated by chromatographic methods, e.g. continuous simulated moving bed (SMB) chromatography or centrifugal partition chromatography (CPC) (Gdtz M.R, Dissertation, Julius Maximilians Universitat Wurzburg 2018), and terpenes such as alpha- bisabolol, guaiol, beta-caryophyllene and terpene(s) selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol can be e.g. isolated by short path distillation and purified by liquid gas chromatography (Breitmaier E., John Wiley & Sons 2012, ISBN: 978-3-527-31498-0; Rostagno, M.A. and Prado J.M., Royal Society of Chemistry, 2013, ISBN: 978-1 -84973-606-0; Patil A.S., Studera Press 2020, ISBN: 978-9-38588-319-4, Mandal S.C., Mandal V., and Das A.K., Academic press 2015, ISBN: 9780128023259).In the present invention, it is preferred that the composition for use of the invention naturally comprises THC, alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, paracymene, isopulegol and geraniol. That is, the composition for use of the present invention preferably comprises an extract derived from / obtainable from a plant that does endogenously contain or produce THC(A), alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha- terpinene, para-cymene, isopulegol and geraniol. In the context of the present invention, the term "extract", without further specification, is intended to generally refer to any form of the product of extraction, optionally minus the extracting agent, regardless of the physical form (e.g. viscous, pasty or solid). In case the extract is derived from / obtainable from a plant, such extract is referred to as "plant extract". Accordingly, in the context of the present invention, the term "plant extract" refers to an extract of plant material in a suitable extractant, optionally minus the extractant.Such plant extract may preferably be derived from / obtainable from a plant that does endogenously contain or produce cannabinoids, cannabinoid-like substances and / or cannabimimetic compounds as well as terpenes and / or terpenoids, provided that such plant is capable of producing THC(A), alpha-bisabolol, guaiol, beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha- terpinene, para-cymene, isopulegol and geraniol. The skilled person will understand that a plant that does endogenously contain or produce cannabinoids, cannabinoid-like substances and / or cannabimimetic compounds as well as terpenes and / or terpenoids may be genetically modified, i.e. it may be a transgenic plant or a transgenic plant cell which differs from naturally occurring ones due to genetic modification. The term "cannabinoid" as used herein relates to any cannabinoid that has been isolated from a plant or has been synthetically or recombinantly created to have activity in the endocannabinoid system, and includes cannabinoid-like substances and / or cannabimimetic compounds. Cannabinoids synthesized by plant sources are consideredto be phytocannabinoids, i.e. plant-based cannabinoids. In the context of the present invention, the term "cannabinoid" may be interchangeably used with "phytocannabinoids". The term "cannabinoid fraction" is used to describe the combination of cannabinoid, cannabinoid-like substances or cannabimimetic compounds present in the plant extract. To date, over 100 cannabinoids have been identified in Cannabis plants. A comprehensive, non-limiting lists of such cannabinoids in Cannabis may be found in ElSohly M. A. and Gul W., in Handbook of Cannabis, Oxford University Press (2014), pp.3-22 and Radwan, M.M. et al. Molecules 2021 , 26(9): 2774. One such example is delta-9-tetrahydrocannabinol (THC). The term "terpene(s)" or "terpenoid(s)" as used herein refers to a class of hydrocarbon molecules. Terpenes are derived from units of isoprene, such that the basic molecular formula of terpenes are multiples of the isoprene unit, i.e. (CsHsK wherein n is the number of linked isoprene units. Examples thereof are alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. Exhaustive lists of Cannabis terpenes are further well-known in the art and include inene, terpineol, valencene, beta-bisabolol, phellandrene, carene, fenchol, borneol, phytol, sabinene, camphor, isoborneol, menthol, and cedrane (Radwan, M.M. et al. Molecules 2021 , 26(9): 2774). Terpenoids are terpene compounds that have been further metabolized in the plant, typically through an oxidative process, and therefore usually contain at least one oxygen atom. The term "terpene fraction" is used to describe the combination of terpene and terpenoid compounds present in the plant extract. Cannabinoids are described to be unique terpenophenolic metabolites found only in Cannabis plants (Sirikantaramas and Taura, Springer 2017, 1 st edition, Chapter s, pp. 183-206). However, alternative cannabinoid-like substances or cannabimimetic compounds can not only be found in Cannabis but also in other plant species including Acmella oleracea (Dallazan et al., Inflammopharmacology 2019, 28, pp.175-186), Echinaceae angustifolia (Raduner et al., J Biol Chem. 2006, 281 (20), pp. 14192-14206), Echinaceae purpurea (Raduner et al., J Biol Chem. 2006, 281 (20), pp. 14192-14206), Helichrysum umbraculigerum (Pollastro et al., Fitoterapia 2018, 126, pp. 35-39), Heliopsis helianthoides (Hajdu et al., J Nat Prod. 2014, 77(7), pp. 1663-1669), Lepidium meyenii (Hajdu et al., J Nat Prod. 2014, 77(7), pp. 1663-1669), Piper methysticum (Ligresti et al., Pharmacol Res. 2012, 6(2), pp. 163-169), Piper nigrum (Reynoso-Moreno et al., J Agric Food Chem. 2017, 65(43), pp. 9435-9442), Radula marginata (Hussain et al., Phytochem rev. (2019), 18, pp. 953-965), Radula perrottetii (Chicca et al., Neurophysiol. 2018,4(10)), Rhododendron anthopogonoides (Iwata and Kitanaka, Chem Pharm Bull. 2011 , 59(1 1 ), pp. 1409-1412) and Tuber melanosporum (Degenhardt et al., Biology, Pharmacology, Diagnosis, and Treatment 2017, Chapter 2, p. 13-23), (Pacioni et al., Phytochemistry 2015, 110, pp. 104-110).Accordingly, in the context of the present invention, the composition for use of the present invention may also comprise an extract derived from / obtainable from a plant that is capable of producing cannabinoids, cannabinoid-like substances or cannabimimetic compounds as well as terpenes and / or terpenoids, but does not endogenously contain or produce them. As such, the skilled person will understand that the plant extract may be obtainable from transgenic plants or plant cells which differ from naturally occurring ones due to genetic modification. Genetically modified plants or plant cells do not naturally occur, i.e., cannot be found in nature, and differ substantially from naturally occurring plants or plant cells due to the introduction of foreign genetic material, for example a foreign nucleic acid molecule. For example, the plant extract used in the present invention may also be derived from a transgenic plant, capable of heterologously producing THC(A), alpha-bisabolol, guaiol beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol in a biosynthetic process. In case the composition for use of the invention comprises an extract derived / obtained from a plant as described herein, it is preferred that the extract has substantially the same THC / terpene ratio as the original plant used to obtain the extract and may concentrates it into a more potent form. Further, in the context of the present invention, it may be preferred that the plant extract is also decarboxylated to ensure that THCA as endogenously present in the plant extract is converted into THC.In the context of the present invention, the term "plant" refers to any various photosynthetic, eukaryotic multicellular organisms of the kingdom Plantae, characteristically producing embryos, containing chloroplasts, having cellulose cell walls and lacking locomotion. As used herein, a "plant" includes any plant or part of a plant at any stage of development and progeny thereof containing cannabinoid, terpene and terpenoid compounds. The plant material may be obtained from solid plant material but is not limited thereto. The solid plant material may be obtained from the whole plant orparts thereof, which include plant cells, plant organs, leaves (in the context of the present invention, the term "leaves" includes any plant leave including flower leaves, sugar leaves, fan leaves and the like), flowers, stems, fruits, roots, trichomes, meristems, plant seeds, protoplasts, callus, and any groups of plant cells organized into structural and / or functional units. Moreover, in the context of the present invention, the plant material may be a plant cell culture, specifically a plant suspension cell culture in a liquid medium. Methods to establish an in vitro plant cell culture from solid plant material are known to those skilled in the art and include callogenesis (Espinosa-Leal et al., Planta (2018), 248:1-18). In the present invention, when a Cannabis plant is used to obtain the extract as described herein which is preferably comprised in the composition for use of the present invention, the plant material is preferably trichome-rich material of the plant. Accordingly, in the present invention, the plant material is preferably obtained from the flower material of the Cannabis plant. In case the flower material is obtained from a Cannabis plant, the flower material is preferably trimmed and dried before use and the flower material subjected to extraction is preferably not exceeding the shelf-life."Drying" as used herein means that the water / moisture in the plant material is reduced. Several drying methods are known to the skilled person, including freeze drying. In the context of the present invention, it is preferred that drying is performed in a drying chamber by placing the plant material on trays through which air flows. Such drying in a drying chamber normally takes place at a temperature of 18°C to 30°C by continuous flow of dehumidified air through the product. In the context of the present invention, drying preferably takes at least 4 days (96 h) or until the water content of the plant material, e.g. flower material, is below 10 percent. The skilled person is aware how to measure the temperature via standard methods. Furthermore, the skilled person knows how to determine the water content in plant material, for example as described in European Pharmacopoeia 10th Edition, Deutscher Apotheker Verlag 2019, ISBN: 978-3-7692- 7453-0. The term "trimming" in the context of the flower material as used herein means that the leaves, particularly the sugar leaves and / or fan leaves, are removed from the flowers. Trimming of the flower material may be performed as described in the following. The flowers of the Cannabis plant may be separated from the rest of the plant manually (e.g. by hand with a scissors) or with a destalker (e.g. MB Bucker 500; Master Bucker 500; www.masterproducts.es).The terms "flower", "flower material" and "blossom" may be used interchangeably herein. The skilled person knows that in Cannabis plants the flowers are arranged in so-called colas. Accordingly, flower material as used herein also refers to said colas. The leaves of the Cannabis plants may be distinguished in fan leaves and sugar leaves. Fan leaves are the large, primary leaves on the Cannabis plant. Sugar leaves develop and grow out of Cannabis flowers in the plant's flowering stage. In the present invention, it is preferred that said sugar leaves are removed from the flower material as described herein.Trichomes (i.e. resin glands) of the Cannabis plant material are nearly microscopic, mushroom-like protrusions from the surface of the Cannabis plant, mainly of the flower buds. While relatively complex, trichomes are comprised primarily of a stalk and a head. The production of cannabinoids such as THC occurs predominantly in the head of the trichome. Cannabinoids are concentrated in the trichomes of the plant. Accordingly, it is evident for the skilled person that the extract as described herein may be provided by using (isolated) trichomes of Cannabis plants.In the context of the present invention, the plant material used to obtain the extract may be fresh, freeze dried, dried or frozen, but is preferably dried. In addition to trimming the plant material used herein, it may be broken down to produce a plant material of a smaller size. In other words, the plant material may also be mechanically comminuted prior to or during mixing with the extractant. All comminution methods known to the person skilled in the art are suitable including smashing, milling, grinding, and chipping (Salman, A. D., Ghadiri M., and Michael Hounslow M.J., Elsevier Science & Technology 2007, ISBN: 978- 0-08055-346-7). The plant extract as described herein can be a crude extract or can optionally be subjected to further customary steps, such that the extract may also be, without limitation, fractionated, sub-fractionated, separated, isolated, purified and / or subjected to centrifugation, purification, and / or concentration. Concentration may be performed by methods known in the art. In the context of the present invention, the extraction solvent is preferably concentrated via evaporation in vacuo by using a rotary evaporator. As a matter of example, vacuum evaporation may be performed in a water bath with 72°C temperature, a pressure of 185 mbar, and a rotation speed of 150 rpm. In the present invention, it is preferred that, in that way, an almost solvent-free extract is established. The skilled person will appreciate that other suitable conditions for vacuum evaporation are known in the art and could be easily established. Thus, in the present invention it is preferred that the composition for use of the invention, if comprising a plantextract, comprises an extract which has been subjected to evaporation, e.g. as described above. In other words, in the present invention it is preferred that, in case the composition for use of the present invention comprises an extract, the accompanied extractant / solvent as described herein is completely or almost completely removed prior to incorporation of the extract into the composition for use of the invention, such that the composition is solvent-free or almost solvent free. Further, it is preferred that such extract has been subjected to decarboxylation to produce THC from THCA.In the present invention, it is even more preferred that the extract is a plant extract obtained from a Cannabis plant or a progeny thereof (hereinafter termed "Cannabis plant extract" or "Cannabis soft extract"). In the context of the present invention, the term "Cannabis plant(s)" is understood as describing a plant of the genus Cannabis (Family Cannabaceae). Species of the genus Cannabis include Cannabis sativa and Cannabis indica, and Cannabis varieties are known in the art, such as Jack Herer, Chemdawg, Bubba Kush, Trainwreck, Super Silver Haze, Pure Kush, El Nino, Himalayan Gold, Skunk #1, White Widow, Warlock CBD, Pink Kush, OG Kush, Super Lemon Haze, Jack the Ripper, Lemon Skunk, and Hash Plant. Furthermore, it includes the Cannabis plants resulting from genetic crosses, self-crosses, natural selections or hybrids of the above- mentioned plants and Cannabis chemovars. Even more preferably, the plant extract, i.e. Cannabis plant extract, is obtained from a Cannabis plant of the strain "Jack Herer" or a progeny thereof. In the context of the present invention, such progeny may be a Cannabis plant as obtained, for example but not limited thereto, by natural selection of seeds of a Cannabis plant, e.g. of the strain "Jack Herer". Cannabis plants, e.g. of the strain "Jack Herer", may be selected for production of THC(A), alpha-bisabolol, guaiol, betacaryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, betapinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol by a process as exemplarily described in the following. Cannabis plant seeds, e.g. of the strain "Jack Herer", may be commercially obtained. The seeds may be cultivated by ordinary cultivation methods known to the skilled person, e.g. for between 3 to 14 days until germination. Based on germination and growing behavior, the skilled person can select specific seeds for further cultivation. Such decisions may generally be made based upon analytical results and / or observations by the cultivar during cultivation. Once the selected seeds are germinated and rooted, they may be further cultivated for three to six weeks by ordinary cultivationmethods known to the skilled person to establish a stock of seed plants. Fertilization, water supply, pest control, disease monitoring and trimming of the plants may be optimized by a skilled person. Based on growing behaviour, the skilled person can select specific seed plants for further cultivation. From these selected plants (in the following passage referred to as individual plants), cuttings may be taken to secure genetic material of the individual plant. The individual plants may then be brought into flowering phase by reducing daylength from > 18 hours to < 12 hours of daylight. Generally, the environmental conditions for rooting, vegetative and flowering phase need to be fulfilled. Then, the individual plants may finally be selected based on the following criteria: growing behavior, flowering behavior, successful cultivation and good rooting behavior of cuttings taken therefrom, susceptibility to diseases (e.g. grey mould) and analytical results for e.g. THC content, content of other cannabinoids and terpene profile. As part of the selection process, batch-to-batch consistency may be analysed based on cannabinoid and terpene profile. Alternative ways of obtaining such progeny may be, for example, selective breeding or cross breeding, and genetic engineering by using methods such as CRISPR / Cas technology. The skilled person routinely knows methods how to test such progenies for THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha- humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, betamyrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alphaterpinene, para-cymene, isopulegol and / or geraniol production, e.g. by using TLC, HPLC or GC with mass spectrometric detection as described above. Such selected progenies, i.e. chemovars (plants distinguished by the cannabinoids produced, rather than the morphological characteristics of the plant), can be bred by a variety of plant breeding techniques which will be familiar to a person skilled in the art. Propagation of the plants by cuttings for production material ensures that the genotype is fixed and that each crop of plants contains the cannabinoids in substantially the same ratio.Most preferably, the plant extract, i.e. Cannabis plant extract, used in the present invention is obtained by a Cannabis variety referred to as D KJ 127 and deposited by the Community Plant Variety Office (deposited by Vertanical GmbH with the application number A202104053 (provisional designation of the variety: dk-j127; Botanical taxon: Cannabis sativa L.; Breeder’s reference: DK-J127; Variety denomination: DKJ127; Application No.: 2021 / 3223; Electronic Application No: A202104053; Date of receipt by the Community Plant Variety Office: 09 / 12 / 2021 )) and / or obtained by the process as described in patent application EP22154007.3 (PCT / EP2023 / 052073). The Cannabisplant extract as described herein may comprise a saponifiable fraction comprising e.g. fatty acids and triglycerides, and an unsaponifiable fraction comprising e.g. cannabinoids such as THC(A) and CBG as well as terpenes and / or terpenoids. The saponifiable fraction is understood as the portion of total lipid in the extract that, after treatment with hot alkali, is soluble in water and insoluble in ether. In the present invention, the saponifiable fraction may be between 5% and 20%, 5% and 30%, or 5% and 40% of the Cannabis plant extract as disclosed herein. Preferably, the saponifiable fraction may be between 10% and 20% of the Cannabis plant extract as disclosed herein. In the present invention, the unsaponifiable fraction may be between 60% and 95%, 70% and 95%, or 80% and 95% of the Cannabis plant extract as disclosed herein. THC(A) as comprised in the unsaponifiable fraction may constitute more than 50%, 60%, 70%, 80% or 85% of the Cannabis plant extract as disclosed herein. Preferably, THC(A) as comprised in the unsaponifiable fraction constitutes more than 85%, preferably between 80% or 90% of the Cannabis plant extract as disclosed herein. Alpha-bisabolol as comprised in the unsaponifiable fraction may constitute more than 0.1 %, 0.2%, 0.25%, 0.27%, 0.275%, 0.28%, 0.3% or 0.4% of the Cannabis plant extract as disclosed herein. Preferably, alpha- bisabolol as comprised in the unsaponifiable fraction constitutes more than 0.25% of the Cannabis plant extract as disclosed herein, preferably between 0.25% and 0.35% of the Cannabis plant extract as disclosed herein. Guaiol as comprised in the unsaponifiable fraction may constitute more than 0.3%, 0.4%, 0.49%, 0.5%, 0.6%, or 0.7% of the Cannabis plant extract as disclosed herein. Preferably, guaiol as comprised in the unsaponifiable fraction constitutes more than 0.49% of the Cannabis plant extract as disclosed herein, preferably between 0.49% and 0.67% of the Cannabis plant extract as disclosed herein. Beta-caryophyllene as comprised in the unsaponifiable fraction may constitute more than 0.3%, 0.4%, 0.49%, 0.5%, 0.6%, or 0.7% of the Cannabis plant extract as disclosed herein. Preferably, beta-caryophyllene as comprised in the unsaponifiable fraction constitutes more than 0.5% of the Cannabis plant extract as disclosed herein, preferably between 0.5% and 0.73% of the Cannabis plant extract as disclosed herein. Each one of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol as comprised in the unsaponifiable fraction may constitute more than 0.001 %, 0.005%, 0.01 %, 0.05%, 0.1 %, or 0.25% of the Cannabis plant extract as disclosed herein. Linalool as comprised in the unsaponifiable fraction preferably constitutes between 0.09% and 0.17% of the Cannabis plant extract as disclosed herein, alpha-humulene as comprisedin the unsaponifiable fraction preferably constitutes between 0.15% and 0.29% of the Cannabis plant extract as disclosed herein, nerolidol as comprised in the unsaponifiable fraction preferably constitutes between 0.12% and 0.23% of the Cannabis plant extract as disclosed herein, caryophyllene oxide as comprised in the unsaponifiable fraction preferably constitutes between 0.02% and 0.06% of the Cannabis plant extract as disclosed herein, alpha-pinene as comprised in the unsaponifiable fraction preferably constitutes between 0.006% and 0.02% of the Cannabis plant extract as disclosed herein, camphene as comprised in the unsaponifiable fraction preferably constitutes between 0.003% and 0.07% of the Cannabis plant extract as disclosed herein, beta-pinene as comprised in the unsaponifiable fraction preferably constitutes between 0.005% and 0.02% of the Cannabis plant extract as disclosed herein, beta-myrcene as comprised in the unsaponifiable fraction preferably constitutes between 0.01 % and 0.04% of the Cannabis plant extract as disclosed herein, limonene as comprised in the unsaponifiable fraction preferably constitutes between 0.02% and 0.05% of the Cannabis plant extract as disclosed herein, eucalyptol as comprised in the unsaponifiable fraction preferably constitutes between 0.005% and 0.01 % of the Cannabis plant extract as disclosed herein, ocimene as comprised in the unsaponifiable fraction preferably constitutes between 0.01 % and 0.03% of the Cannabis plant extract as disclosed herein, gamma-terpinene as comprised in the unsaponifiable fraction preferably constitutes between 0.005% and 0.015% of the Cannabis plant extract as disclosed herein, terpinolene as comprised in the unsaponifiable fraction preferably constitutes between 0.005% and 0.01 % of the Cannabis plant extract as disclosed herein, alpha-terpinene as comprised in the unsaponifiable fraction preferably constitutes between 0.005% and 0.01 % of theCannabis plant extract as disclosed herein, para-cymene as comprised in the unsaponifiable fraction preferably constitutes between 0.006% and 0.02% of theCannabis plant extract as disclosed herein, isopulegol as comprised in the unsaponifiable fraction preferably constitutes between 0.01 % and 0.05% of the Cannabis plant extract as disclosed herein, and / or geraniol as comprised in the unsaponifiable fraction preferably constitutes between 0.02% and 0.05% of the Cannabis plant extract as disclosed herein.It is preferred that the cannabinoid fraction in the unsaponifiable fraction, excluding THC as main cannabinoid, may be present in an amount of not more than 5% by weight of the Cannabis plant extract.The skilled person knows routine procedures to produce the composition for use of the invention comprising e.g. a fixed content of THC, alpha-bisabolol, guaiol, betacaryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gammaterpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol from a plant extract. An exemplary procedure is described in the following: The plant extract, e.g. Cannabis plant extract, is intended to be standardized with a carrier oil, e.g. refined sesame oil of pharmaceutical grade, to a THC content of 5% (by weight of the composition) to provide the composition for use of the invention. This standardization may be performed in multiple, e.g. three, dilution steps. An analytical sample is taken in each dilution step and the THC content is determined via HPLC analysis to enable a precise determination of the remaining amount of carrier oil necessary to adjust the prior dilution to the desired content of 5% THC. After HPLC analysis, only 80% of the calculated remaining amount of carrier oil is added. In the last dilution step, the correct amount of carrier oil as calculated is added to provide the composition for use of the invention comprising the desired content of 5% THC by weight of the composition.In the present invention, it is preferred that the plant extract as described herein is preferably substantially free of waxes and other non-specific lipid soluble material but preferably contains substantially all of the cannabinoids naturally present in the plant, most preferably in substantially the same ratios in which they occur in the intact plant, e.g. Cannabis plant.In the present invention, the plant extract as defined herein is obtainable by extraction of plant material. Any extract obtained by solvent extraction, distillation methods, pressing and sublimation, decoction, digestion, percolation, maceration or any other appropriate extraction method known to the person skilled in the art, or a combination thereof may be used such as described in Rostagno, M.A. and Prado J.M., Royal Society of Chemistry, 2013, ISBN: 978-1 -84973-606-0, Patil A.S., Studera Press 2020, ISBN: 978-9-38588- 319-4, and Mandal S.C., Mandal V., and Das A.K., Academic press 2015, ISBN: 9780128023259. In the present invention, the extract as described herein is preferably obtained by a combination of maceration and percolation, maceration being preferably applied first.Extracts may be formed by contacting an extractant with the plant material as defined herein. Preferred herein is solvent extraction, i.e. extraction using a solvent. It isenvisaged that the plant material, preferably the Cannabis plant material is brought into contact with the solvent, which may also be called the extractant. In other words, in the context of the present invention, the term "extractant" refers to a suitable solvent used in the extraction of a substance from a liquid or solid material. As such, the plant material, preferably the Cannabis plant material, is treated with a solvent. In the present invention, it is preferred that the plant extract as defined herein is obtainable by solvent extraction. Solvent extraction is a technique whereby soluble organic compounds can be extracted from solids using extracting solvents. As described above, extraction as described herein is preferably performed by percolation. Percolation is understood as process whereby, unless otherwise prescribed, the herbal drug to be extracted is reduced to pieces of suitable size and mixed thoroughly with a portion of the prescribed extraction solvent and allowed to stand for an appropriate time. The mixture is prepared in or transferred to a percolator and more extraction solvent is added until the herbal drug is covered with a layer of extraction solvent. Subsequently, the percolate is allowed to flow slowly from the base of the percolator and collected in a tank. Percolation continues until the percolate is recovered. If the residue is pressed, the two liquids are combined. It is envisaged that the desired (pharmaceutically active) substances from the plant material dissolve in the solvent. Accordingly, it is envisaged that the e.g. cannabinoids (preferably THC) and / or other (pharmaceutically active) substances (preferably alpha-bisabolol, guaiol, betacaryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gammaterpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol) from the Cannabis plant material dissolve in the solvent. That means that after the treatment of the Cannabis plant material with the solvent the e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmaceutically active) substances (e.g. terpenes, preferably alpha- bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol) are no longer present in the Cannabis plant material but are dissolved in the solvent. In other words, the solvent "removes" the e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmaceutically active) substances (e.g. terpenes) from the plant material. In other words, the e.g. cannabinoids (preferably THC) and / or other (pharmaceutically active) substances (e.g. terpenes) are extracted from the plant material. The solvent with the dissolved e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmaceutically active) substances (e.g. terpenes) can then be separated (i.e.extracted) from the plant material. The solvent with the dissolved e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmaceutically active) substances (e.g. terpenes) separated from the plant material, preferably Cannabis plant material, is called the plant extract, preferably Cannabis plant extract.The extraction time and temperature may vary depending on the extraction media and method, and may be readily optimized by a skilled person. An extraction time between 1 h and 10 days may be applied. More particularly, a time between 85 to 120 h, and preferably a time between 93 and 110 h may be applied. The temperature used for extraction may preferably be between 15°C and 25°C. The extraction process is preferably performed by exclusion of light.Non-limiting examples of solvents that may be suitable are alcohols (e.g. methanol, ethanol, propanol, butanol, propylene glycol etc.), water, hydrocarbons (e.g. butane, hexane, etc.), polar organic solvents (e.g. ethyl acetate, polyethylene glycol, etc.) or a supercritical fluid (e.g. liquid CO2). Suitable non-polar solvents may be C5-C12 straight chain or branched chain alkanes, C1 -C12 alcohols or carbonate esters of C1 -C12 alcohols. The more volatile solvents may be particularly useful, as they are more easily removed from the extract if desired. Although completely evident for the skilled person, it is pointed out that also mixtures of the mentioned solvents may be used for the herein described methods. Preferably, the solvent is selected from the group of ethanol, butanol, pentane, heptane, propane, ethyl ether, tert-butyl-methyl-ether, methyl-ethyl-ketone, acetone, ethyl acetate and CO2. Corresponding solutions may contain the solvent, e.g. the alcoholic solvent, in any volume / volume (v / v) ratio suitable for extraction. In the context of the present invention, extraction is most preferably carried out using ethanol with 96% (v / v) as solvent. In the context of the present invention, solvents of pharmaceutical grade are preferably used.Suitable conditions conducive for extraction are known to the skilled artisan. Specific parameters such as temperature, ratio of solvent / plant material and extraction time may be optimized. The skilled person can readily determine suitable ratios of plant material to solvent. As a matter of example, in case extraction is carried out using ethanol with 96% (v / v), a cost and time efficient extraction process may be carried out using between 15.9 kg and 17.5 kg (e.g. 16.7 kg) 96% (v / v) ethanol per kg of dried flowers. The solvent / extractant as described herein is preferably of pharmaceutical grade. Accordingly,the plant material, preferably, Cannabis plant material, more preferably, flower material of a Cannabis plant described herein and the solvent are preferably present in a ratio of about 1 :16.8 (w / w). The term "about" as used herein means 10 percent more or 10 percent less than the denoted value.In the present invention, any method suitable to provide the extract as described herein may be used. Suitable methods to prepare such an extract are routinely known to the skilled person and are further described in the foregoing detailed description. In the present invention, the plant extract is preferably obtainable by solvent extraction of a plant suitable to provide the extract as described herein, a Cannabis plant being mentioned as preferred example. Even more preferably, the plant extract is obtainable by solvent extraction of the flower material of a Cannabis plant as described herein. As such, the plant extract comprised in the composition of the invention may even more preferably be obtained by solvent extraction of the flower material of a Cannabis plant. In the present invention it is most preferred that the plant extract, which may be comprised in the composition for use of the invention, may be obtained by solvent extraction of the flower material of the Cannabis plant as deposited by the Community Plant Variety Office with the application number A202104053 or is the plant extract as obtainable by / produced by the process as described in patent application EP22154007.3 (PCT / EP2023 / 052073). Flower material used for extraction in the context of the invention, e.g. flower material of the Cannabis plant as deposited by the Community Plant Variety Office with the application number A202104053 is preferably trimmed and dried prior to subjection to extraction and / or decarboxylation.The extract as described herein can be any extract suitable to provide the composition for use of the present invention and, thus, may be present in liquid, viscous, pasty or solid form. In the context of the present invention, it is preferred that the extract as described herein is present in liquid form, and more specifically, as an aqueous, alcoholic extract after evaporation. As such, the extract used to provide the composition for use of the present invention is most preferably an aqueous, alcoholic extract obtained by solvent extraction of the flower material of the Cannabis plant as deposited by the Community Plant Variety Office with the application number A202104053 after evaporation and / or decarboxylation. In the context of the present invention, the composition for use of the invention may also comprise the plant extract as obtainable by / produced by the process as described in the patent application EP22154007.3 (PCT / EP2023 / 052073).In the context of the present invention, it should be noted that the composition for use of the invention may comprise the extract as described herein, but does not consist of the extract as described herein. In other words, in the context of the present invention, the composition for use of the invention comprises the extract as described herein, preferably the plant extract as described herein, and at least one suitable further substance. That is, the composition for use of the invention may comprise the extract, e.g. plant extract, as described herein or a multitude of different extracts, e.g. plant extracts, as described herein, and at least one suitable further substance. In the present invention, it is preferred that the composition for use of the invention may comprise the extract as described herein and a suitable carrier oil (or a mixture of such oils) in a suitable amount. As an example, the composition for use of the invention comprises / consists of the extract as described herein and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to between about 2.5% and 10% or to 5% by weight of the composition. In another example, the composition for use of the invention comprises / consists of the extract as described herein and a carrier oil as described herein (or a mixture of such oils) such that the alpha-bisabolol content of the composition is adjusted to between 0.008% and 0.065%, preferably between 0.01 % and 0.04%, or most preferably between 0.017% and 0.031 % by weight of the composition, the guaiol content of the composition is adjusted to between 0.012% and 0.092%, preferably between 0.015% and 0.05%, or most preferably between 0.025% and 0.046% by weight of the composition, the beta-caryophyllene content of the composition is adjusted to between 0.012% and 0.094%, preferably between 0.02% and 0.05% or most preferably between 0.025% and 0.047% by weight of the composition and / or the content of one or more of linalool is adjusted to between 0.001 % and 0.014%, preferably between 0.003% and 0.0085% by weight of the composition, alpha-humulene is adjusted to between 0.003% and 0.028%, preferably between 0.006% and 0.017% by weight of the composition, nerolidol is adjusted to between 0.004% and 0.035%, preferably between 0.007% and 0.021 % by weight of the composition, caryophyllene oxide is adjusted to between 0.001 % and 0.0092%, preferably between 0.001 % and 0.0055% by weight of the composition, alpha-pinene is adjusted to between 0.0001 % and 0.002%, preferably between 0.0002% and 0.001 % by weight of the composition, camphene is adjusted to between 0.00001 % and 0.0015%, preferably between 0.00003% and 0.00082% by weight of the composition, beta-pinene is adjusted to between 0.0001 % and 0.0015%, preferably between 0.0001 % and 0.00092% by weight of the composition, beta-myrcene is adjusted to between0.0004% and 0.005%, preferably between 0.0004% and 0.005% by weight of the composition, limonene is adjusted to between 0.0005% and 0.004%, preferably between 0.0008% and 0.0022% by weight of the composition, eucalyptol is adjusted to between 0.00006% and 0.002%, preferably between 0.0001 % and 0.0012% by weight of the composition, ocimene is adjusted to between 0.00005% and 0.004%, preferably between 0.00009% and 0.0023% by weight of the composition, gamma-terpinene is adjusted to between 0.00007% and 0.002%, preferably between 0.0001 % and 0.0013% by weight of the composition, terpinolene is adjusted to between 0.00002% and 0.002%, preferably between 0.00003% and 0.001 % by weight of the composition, alpha-terpinene is adjusted to between 0.00004% and 0.002%, preferably between 0.00006% and 0.0012% by weight of the composition, para-cymene is adjusted to between 0.00004% and 0.002%, preferably between 0.00007% and 0.0013% by weight of the composition, isopulegol is adjusted to between 0.0003% and 0.003%, preferably between 0.0005% and 0.0015% by weight of the composition, and geraniol in is adjusted to between 0.0001 % and 0.008%, preferably between 0.0002% and 0.0044% by weight of the composition.In a more preferred example, the composition for use of the invention comprises / consists of the extract as described herein and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to between about 2.5% and 10%, more preferably to 5% by weight of the composition, the alpha-bisabolol content of the composition is adjusted to between 0.008% and 0.065%, preferably between 0.01 % and 0.04%, or most preferably to between 0.017% and 0.031 % by weight of the composition, the guaiol content of the composition is adjusted to between 0.012% and 0.092%, preferably between 0.015% and 0.05%, or most preferably to between 0.025% and 0.046% by weight of the composition, the beta-caryophyllene content of the composition is adjusted to between 0.012% and 0.094%, preferably between 0.02% and 0.05%, or most preferably to between 0.025% and 0.047% by weight of the composition, linalool is adjusted to between 0.001 % and 0.014%, preferably between 0.003% and 0.0085% by weight of the composition, alpha-humulene is adjusted to between 0.003% and 0.028%, preferably between 0.006% and 0.017% by weight of the composition, nerolidol is adjusted to between 0.004% and 0.035%, preferably between 0.007% and 0.021 % by weight of the composition, caryophyllene oxide is adjusted to between 0.001 % and 0.0092%, preferably between 0.001 % and 0.0055% by weight of the composition, alpha-pinene is adjusted to between 0.0001 % and 0.002%, preferably between 0.0002% and 0.001 % by weight of the composition, camphene is adjusted to between 0.00001 %and 0.0015%, preferably between 0.00003% and 0.00082% by weight of the composition, beta-pinene is adjusted to between 0.0001 % and 0.0015%, preferably between 0.0001 % and 0.00092% by weight of the composition, beta-myrcene is adjusted to between 0.0004% and 0.005%, preferably between 0.0004% and 0.005% by weight of the composition, limonene is adjusted to between 0.0005% and 0.004%, preferably between 0.0008% and 0.0022% by weight of the composition, eucalyptol is adjusted to between 0.00006% and 0.002%, preferably between 0.0001 % and 0.0012% by weight of the composition, ocimene is adjusted to between 0.00005% and 0.004%, preferably between 0.00009% and 0.0023% by weight of the composition, gamma-terpinene is adjusted to between 0.00007% and 0.002%, preferably between 0.0001 % and 0.0013% by weight of the composition, terpinolene is adjusted to between 0.00002% and 0.002%, preferably between 0.00003% and 0.001 % by weight of the composition, alpha-terpinene is adjusted to between 0.00004% and 0.002%, preferably between 0.00006% and 0.0012% by weight of the composition, para-cymene is adjusted to between 0.00004% and 0.002%, preferably between 0.00007% and 0.0013% by weight of the composition, isopulegol is adjusted to between 0.0003% and 0.003%, preferably between 0.0005% and 0.0015% by weight of the composition, and / or geraniol in is adjusted to between 0.0001 % and 0.008%, preferably between 0.0002% and 0.0044% by weight of the composition.Preferably, the composition for use of the invention comprises / consists of the extract as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of between 100:1 and 450:1 , more preferably of between 160:1 and 295:1 , a THC / guaiol ratio of between 50: 1 and 250: 1 , more preferably of between 105: 1 and 200: 1 , a THC / beta-caryophyllene ratio of between 50:1 and 250:1 , more preferably of between 105:1 and 200:1 , a THC / linalool ratio of between 450:1 and 1400:1 , more preferably of between 500:1 and 1330:1 , a THC / alpha-humulene ratio of between 300:1 and 725:1 , preferably of between 355: 1 and 665: 1 , a THC / nerolidol ratio of between 200: 1 and 600: 1 , preferably of between 1090:1 and 2080:1 , a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1 , preferably of between 1090:1 and 2080:1 , a THC / alpha-pinene ratio of between 5850:1 and 16000:1 , preferably of between 6000:1 and 15750:1 , a THC / cam phene ratio of between 7300:1 and 132950:1 , preferably of between 7300:1 and 132950:1 , a THC / beta-pinene ratio of between 6475:1 and 23100:1 , preferably of between 6545:1 and 23025:1 , a TH C / beta-myrcene ratio of between 1950:1 and 6300:1 , preferably of between 2025:1 and 6210:1 , a THC / limonene ratio of between 1650:1 and 5050:1 , preferably of between 1700:1 and 4970: 1 , a THC / eucalyptol ratio of between5050:1 and 38650:1 , preferably of between 5140:1 and 38580:1 , a THC / ocimene ratio of between 2500:1 and 44700:1 , preferably of between 2570:1 and 44610:1 , a THC / gamma- terpinene ratio of between 4700:1 and 35750:1 , preferably between 4800:1 and 35685:1 , a THC / terpinolene ratio of between 5450:1 and 129850:1 , preferably of between 5535:1 and 129965:1 , a THC / alpha-terpinene ratio of between 5150:1 and 58550:1 , preferably of 5210:1 and 58480:1 , a THC / para-cymene ratio of between 4700:1 and 56700:1 , preferably of 4800:1 and 56625:1 , a THC / isopulegol ratio of between 4000:1 and 8000:1 , preferably of between 4060: 1 and 7915: 1 , and / or a THC / geraniol ratio of between 1300: 1 and 18250:1 , preferably of between 1375:1 and 18150:1.The carrier oil, which may provide the composition for use of the invention together with the extract as described herein, may constitute any percentage of such composition provided that such percentage is in conformity with the above presented definitions for the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene and the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alphaterpinene, para-cymene, isopulegol and / or geraniol. In a preferred example, the carrier oil may be present in an amount of between 85% and 97% by weight of the composition. Such carrier oil may be a naturally derived oil (e.g. an essential oil) or one or more waxes or any combination thereof.An "essential oil" is an oil derived by extraction (e.g. steam extraction, or contacting the plant material with an extractant) or pressing, which contains primarily hydrophobic, and generally fragrant, components of the plant material. Suitable naturally derived oils and waxes include sesame oil, olive oil, arnica oil, lavender oil, frankincense oil, lemongrass essential oil, cinnamon leaf oil, rosemary cineole oil, rosemary oil, bergamot oil, myrrh oil, sage oil, coconut oil, hemp seed oil, castor oil, bees wax or any other edible oil, or a combination thereof. Preferably, the carrier oil may be selected from the following list of sesame oil, rapeseed oil, peanut oil, almond oil, wheat germ oil, sunflower oil, olive oil, cottonseed oil, peanut oil, almond oil, borage oil, safflower oil, soybean oil, fish oil, linseed oil and medium chain triglycerides. In the present invention it is most preferred that the composition for use of the invention comprises a plant extract, e.g. the Cannabis plant extract, as described herein, and sesame oil in accordance with the definitions set out above. As explained herein above, the extract as described herein is preferably a plant extract as defined herein and even more preferably a Cannabis plant extract as definedherein. The carrier oil as described herein, which is used to provide the composition of the invention, is preferably refined and of pharmaceutical grade.The composition for use as described herein may contain a native extract, e.g. the plant extract as described herein, or the extract may be additionally modified by changing its composition, e.g., without limitation, by changing the pH or by adding one or more solvents in a preferred concentration. The extract as described herein may also be reconstituted by mixing with a suitable solvent. In some instances, the extract as described herein may also be filtered to remove particulate material, for example, by passing the extract through filter paper, a particle filter or a fine sieve with pore sizes suitable for filtration. As a matter of example, a suitable deposition rate would be 1 .5 pm. The operating pressure and temperature during filtration may be optimized by the skilled person, but should preferably not exceed 5 bar and 50°C. As will be appreciated, one or more additional compounds (e.g. cannabinoid, terpene or terpenoid compounds) may be added to the composition for use as described herein. The addition of compounds may be to compensate for natural variations in the relative amounts of certain compounds being expressed by the Cannabis plant which provides the extract. The added compounds may be natural or synthetic versions of the desired compound(s).References to "THC" or "delta-9-tetrahydrocannabinol" and "Cannabidiol" or "CBD" or "cannabinoid(s)" as used herein, will be understood to also encompass pharmaceutically acceptable salts of such compounds. The term "pharmaceutically acceptable salts" refers to salts or esters prepared from pharmaceutically acceptable non-toxic bases or acids, including inorganic bases or acids and organic bases or acids, as would be well known to persons skilled in the art. Many suitable inorganic and organic bases are known in the art.In the context of the present invention, it is considered that the composition for use of the invention comprises THC as main cannabinoid, however, the optional presence of other cannabinoids including, without limitation, delta-9-tetrahydrocannabinol (A9-THC), delta- 8-tetrahydrocannabinol (A8-THC), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabichromene (CBC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), cannabinol (CBN), cannabigerolic acid (CBGA) and cannabigerol (CBG) is not excluded. Specifically, it will be appreciated that the present composition for use comprising THC as main cannabinoid may comprise low amounts of CBD, for example,less than 20% CBD by weight of the composition, or less than 15%, 10%, 5% or 2.5% CBD by weight of the composition, or may not comprise any measurable CBD. In the present invention, it is preferred that the composition for use of the invention comprises less than 0.5% CBD, or even more preferably less than 0.1 % CBD by weight of the composition. The entirety of cannabinoids, i.e. the cannabinoid fraction, typically accounts for the majority of the compounds present in the composition for use of the invention.In the context of the present invention, the composition for use described herein can be employed in a kit as defined herein.The present invention further provides a pharmaceutical formulation for use of the invention comprising the composition as described herein. That is, the pharmaceutical formulation for use of the invention may comprise the composition as described herein, and at least one suitable further substance. In the present invention, it is preferred that the pharmaceutical formulation for use of the invention may comprise the composition as described herein and a suitable carrier oil (or a mixture of such oils) in a suitable amount. Accordingly, the pharmaceutical formulation for use of the invention essentially comprises the same individual components and an identical THC / alpha-bisabolol, THC / guaiol and THC / beta-caryophyllene as well as THC and linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol or geraniol ratio as the composition of the invention but has been further diluted with a suitable carrier oil (and optionally other additional substances comprised in the pharmaceutical formulation). In the context of the present invention, the composition of the invention is diluted in a particular ratio such that a specific THC content comprised in the resulting pharmaceutical composition for use of the invention is set / fixed.In the present invention, the pharmaceutical formulation for use of the invention comprises the composition of the invention and a suitable carrier oil such that the THC content of the composition is diluted / adjusted to between about 0.1 %, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1 %, 1.1 %, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.05%, 2.1 %, 2.15%, 2.2%, 2.25%, 2.3%, 2.35%, 2.4%, 2.45% and 2.5% by weight of the pharmaceutical formulation. Accordingly, in the context of the present invention, the composition for use of the invention differs from the pharmaceutical formulation for use of the invention by the fact that additional carrier oil is added to obtaina pharmaceutical formulation for use as described herein. Further, in the context of the present invention, the pharmaceutical formulation for use of the invention comprises the composition of the invention and a suitable carrier oil such that the THC content of the composition is diluted / adjusted to below 2.5% by weight of the pharmaceutical formulation. In the present invention, it is preferred that the pharmaceutical formulation for use of the invention comprises the composition of the invention and a suitable carrier oil such that the THC content of the composition is adjusted to between 1 .0% and 2.5%, even more preferably to 2.1 % (2.05 to 2.144 when applying the rounding convention) by weight of the pharmaceutical formulation. In the present invention, the pharmaceutical formulation for use of the invention comprises the composition of the invention and the suitable carrier oil such that the alpha-bisabolol content of the composition is adjusted to between about 0.003% and 0.016% by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to between about 0.01 % and 0.023% by weight of the pharmaceutical formulation the beta-caryophyllene content of the composition is adjusted to between about 0.01 % and 0.024% by weight of the pharmaceutical formulation. Further the skilled person will appreciate that certain terpenes from the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol are present in the composition but may become non-detectable because their concentration may be below the identification threshold or detection limit after dilution to provide the pharmaceutical formulation for use of the invention. Accordingly, the pharmaceutical formulation for use of the invention comprises the composition of the invention and the suitable carrier oil such that the linalool content of the composition is adjusted to between about 0.0007% and 0.004% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to between about 0.001 % and 0.007% by weight of the pharmaceutical formulation, and / or the nerolidol content of the composition is adjusted to between about 0.001 % and 0.009% by weight of the pharmaceutical formulation.In the present invention, it is preferred that the pharmaceutical formulation for use of the invention comprises the composition of the invention and the suitable carrier oil such that the alpha-bisabolol content of the composition is adjusted to between about 0.006% and 0.014% by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to between about 0.01 % and 0.019%, the beta-caryophyllene content of thecomposition is adjusted to between about 0.01 % and 0.02% by weight of the pharmaceutical formulation and / or the linalool content of the composition is adjusted to between about 0.001 % and 0.003% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to between about 0.003% and 0.006% by weight of the pharmaceutical formulation, and / or the nerolidol content of the composition is adjusted to between about 0.003% and 0.008% by weight of the pharmaceutical formulation.In a more preferred example, the pharmaceutical formulation for use of the invention comprises the composition of the invention and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to between about 1.0% and 2.5% by weight of the pharmaceutical formulation, the alpha-bisabolol content of the composition is adjusted to between 0.003% and 0.016% by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to between 0.01 % and 0.023% by weight of the pharmaceutical formulation, and / or the betacaryophyllene content of the composition is adjusted to between 0.01 % and 0.024% by weight of the pharmaceutical formulation, the linalool content of the composition is adjusted to between about 0.0007% and 0.004% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to between about 0.001 % and 0.007% by weight of the pharmaceutical formulation, and / or the nerolidol content of the composition is adjusted to between about 0.001 % and 0.009% by weight of the pharmaceutical formulation. In the present invention, the pharmaceutical composition for use of the invention most preferably comprises the components set out in Table 2 below.Table 2: Most preferred amounts of components comprised in the pharmaceutical formulation for use of the invention.In the present Examples three different lots of the pharmaceutical formulation for use of the present invention are tested. The components comprised in the three pharmaceutical formulations are set out in Table 3 below.Table 3: Components comprised in the three pharmaceutical formulation lots used in the present Examples.Accordingly, in an exemplary embodiment of the present invention the pharmaceutical formulation for use of the invention comprises the composition of the invention and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to 2.110% by weight of the pharmaceutical formulation, the alpha- bisabolol content of the composition is adjusted to 0.010% by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to 0.013% by weight of the pharmaceutical formulation, the beta-caryophyllene content of the composition is adjusted to 0.013% by weight of the pharmaceutical formulation, the linalool content of the composition is adjusted to 0.002% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to 0.004% by weight of the pharmaceutical formulation, and the nerolidol content of the composition is adjusted to 0.007% by weight of the pharmaceutical formulation.In another exemplary embodiment of the present invention the pharmaceutical formulation for use of the invention comprises the composition of the invention and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to 2.086% by weight of the pharmaceutical formulation, the alpha- bisabolol content of the composition is adjusted to 0.011 % by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to 0.015% by weight of the pharmaceutical formulation, the beta-caryophyllene content of the composition is adjusted to 0.016% by weight of the pharmaceutical formulation, thelinalool content of the composition is adjusted to 0.002% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to 0.005% by weight of the pharmaceutical formulation, and the nerolidol content of the composition is adjusted to 0.008% by weight of the pharmaceutical formulation.In yet another exemplary embodiment of the present invention the pharmaceutical formulation for use of the invention comprises the composition of the invention and a carrier oil as described herein (or a mixture of such oils) such that the THC content of the composition is adjusted to 2.100% by weight of the pharmaceutical formulation, the alpha- bisabolol content of the composition is adjusted to 0.010% by weight of the pharmaceutical formulation, the guaiol content of the composition is adjusted to 0.015% by weight of the pharmaceutical formulation, the beta-caryophyllene content of the composition is adjusted to 0.014% by weight of the pharmaceutical formulation, the linalool content of the composition is adjusted to 0.002% by weight of the pharmaceutical formulation, the alpha-humulene content of the composition is adjusted to 0.004% by weight of the pharmaceutical formulation, and the nerolidol content of the composition is adjusted to 0.006% by weight of the pharmaceutical formulation.In the present invention, it is preferred that the pharmaceutical formulation for use of the invention comprises / consists of the composition for use as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of between 100:1 and 450:1 , more preferably of 160: 1 and 295: 1 , a THC / guaiol ratio of between 50: 1 and 250: 1 , more preferably of 105:1 and 200:1 , a THC / beta-caryophyllene ratio of between 50:1 and 250:1 , more preferably of 105:1 and 200:1 , a THC / linalool ratio of between 450:1 and 1400:1 , more preferably of 500:1 and 1330:1 , a THC / alpha-humulene ratio of between 300:1 and 725:1 , more preferably of 355:1 and 665:1 , and / or a THC / nerolidol ratio of between 200:1 and 600:1 , more preferably of 270:1 and 535:1.In the exemplary embodiment the pharmaceutical formulation for use of the invention comprises / consists of the composition for use as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of 222, a THC / guaiol ratio of 162, a THC / beta-caryophyllene ratio of 162, a THC / linalool ratio of 1172, a THC / alpha- humulene ratio of 528, and a THC / nerolidol ratio of 320.In another exemplary embodiment the pharmaceutical formulation for use of the invention comprises / consists of the composition for use as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of 190, a THC / guaiol ratio of 139, a THC / beta-caryophyllene ratio of 130, a THC / linalool ratio of 907, a THC / alpha- humulene ratio of 444, and a THC / nerolidol ratio of 274.In yet another exemplary embodiment the pharmaceutical formulation for use of the invention comprises / consists of the composition for use as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of 210, a THC / guaiol ratio of 140, a THC / beta-caryophyllene ratio of 150, a THC / linalool ratio of 913, a THC / alpha- humulene ratio of 500, and a THC / nerolidol ratio of 356.Suitable methods to qualitatively and quantitatively determine, analyze, control or set the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, paracymene, isopulegol and / or geraniol are known in the art and have already been described above and include TLC, HPLC and GC with mass spectrometric detection as described above. The skilled person knows standard procedures how to produce the pharmaceutical formulation for use of the invention by dilution of the composition for use of the invention, exemplary procedures being described in the following: To produce the pharmaceutical formulation for use of the present invention comprising 2.1 % THC by weight of the pharmaceutical formulation, the composition for use of the invention comprising 5% THC by weight of the composition is further diluted to a content of 2.1 % by directly adding the required amount of carrier oil. In another example, 10 g of the composition for use of the invention comprising a THC content of 5% by weight of the composition are weighed, and mixed with 15 g carrier oil, preferably sesame oil (e.g. as comprised in the commercially available Vertanical Production Kit, Vertanical GmbH, catalogue number 15876554), to provide a homogeneous mixture, i.e. the pharmaceutical formulation comprising 2.0% THC by weight of the pharmaceutical formulation.The carrier oil, which - together with the composition as described herein - provides the pharmaceutical formulation for use of the invention, may constitute any percentage of such a pharmaceutical formulation provided that such percentage is in conformity with the above presented definitions for the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene and the terpenes selected from linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol in the pharmaceutical formulation. Such carrier oil may be a naturally derived oil (e.g. an essential oil) or one or more waxes or any combination thereof as disclosed above in the context of the composition for use of the invention. As such, any carrier oil which may be used or is particularly useful in the context of the composition for use of the invention, is applicable in the context of the pharmaceutical formulation for use of the invention.In the context of the present invention, the skilled person will understand that, as applicable to the composition for use of the present invention, the pharmaceutical formulation for use of the present invention comprises THC as main cannabinoid, but the optional presence of other cannabinoids including, without limitation, cannabidiol (CBD) is not excluded. As such, it is envisaged that other cannabinoids, such as for example cannabidiol (CBD), may be added to the composition for use of the present invention or the pharmaceutical formulation for use of the present invention in a desired amount.Both, the composition for use of the present invention and the pharmaceutical formulation for use of the invention may comprise, in addition to the ingredients as described above, further substances such as, without limitation, antioxidants, colorants and flavoring agents in any suitable concentration. Other suitable additives are known to the skilled person and detailed examples are furthermore listed in the continuing detailed description. In case the composition for use of the present invention comprises an extract obtained by extraction, the extractant, e.g. solvent as described herein, may be partially or preferably completely removed prior to incorporation of the composition into the pharmaceutical formulation for use of the invention, e.g. by heating the extract under reduced pressure (e.g. under vacuum). The skilled person is aware that some volatile plant metabolites may be removed with the extractant. In the context of the present invention, the extractant may be included in the pharmaceutical formulation for use of the invention.The terms "composition" and "pharmaceutical formulation" as used herein generally define a composition or formulation suitable for application / administration to the body to treat, care for or improve the appearance of the body. The composition for use of theinvention may be applied / administered to a subject which is a patient, preferably a human patient. The pharmaceutical formulation for use of the invention is specifically intended to be applied / administered to a subject which is a patient, preferably a human patient. As such, the term "pharmaceutical formulation" can be used interchangeably with "medicament". In the present invention, the composition for use and pharmaceutical formulation for use as described herein are particularly useful in medicine. Specifically, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and / or prevention of chronic pain. More specifically, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles.In one embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic pain. In a preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. However, each of the respective conditions can be treated individually. Accordingly, in one embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic low back pain (CLBP). In another embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic non-specific low back pain (CNSLBP). In yet another embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of osteoarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of another chronic specific musculoskeletal condition that affects (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. Accordingly, in a further embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of neck pain. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment offibromyalgia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of rheumatoid arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of psoriatic arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of gout. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of spondylarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of osteoporosis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of osteopenia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of sarcopenia. In a preferred embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic low back pain (CLBP) and / or chronic non-specific low back pain (CNSLBP). In a more preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment of chronic non-specific low back pain (CNSLBP).In one embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic pain. In a preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. However, each of the respective conditions can be treated individually. Accordingly, in one embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic low back pain (CLBP). In another embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic non-specific low back pain (CNSLBP). In yet another embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of osteoarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of another chronic specificmusculoskeletal condition that affects (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. Accordingly, in a further embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of neck pain. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of fibromyalgia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of rheumatoid arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of psoriatic arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of gout. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of spondylarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of osteoporosis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of osteopenia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of sarcopenia. In a preferred embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic low back pain (CLBP) and / or chronic non-specific low back pain (CNSLBP). In a more preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the prevention of chronic non-specific low back pain (CNSLBP).In one embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of chronic pain. In a preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. However, each of the respective conditions can be treated individually. Accordingly, in one embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of chronic low back pain (CLBP). In another embodiment, the composition for use and pharmaceuticalformulation for use of the present invention are used in the treatment and prevention of chronic non-specific low back pain (CNSLBP). In yet another embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of osteoarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of another chronic specific musculoskeletal condition that affects (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. Accordingly, in a further embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of neck pain. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of fibromyalgia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of rheumatoid arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of psoriatic arthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of gout. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of spondylarthritis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of osteoporosis. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of osteopenia. In a further embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of sarcopenia. In a preferred embodiment the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of chronic low back pain (CLBP) and / or chronic non-specific low back pain (CNSLBP). In a more preferred embodiment, the composition for use and pharmaceutical formulation for use of the present invention are used in the treatment and prevention of chronic nonspecific low back pain (CNSLBP).The invention also provides a method for treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditionsthat affect (a) area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles as disclosed herein, the method comprising administering to a patient in need thereof an effective amount of the composition for use or pharmaceutical formulation for use described herein. The term "effective amount" is understood as an amount sufficient that when administered to the patient, the drug is provided to achieve the desired effect. In the case of a therapeutic method, this effect may be the treatment and / or prevention of e.g. CLBP, CNSLBP, osteoarthritis and / or other chronic musculoskeletal pain conditions i.e. such that the "effective amount" is considered as a therapeutically effective amount. The "therapeutically effective amount" refers to administration of an amount of a given compound, to a subject in need thereof that achieves the desired therapeutic effect. The term "consecutively" means that each of the composition or pharmaceutical formulation and the other active agent are administered separately and / or at different times. In the present invention it is preferred that the invention provides a method for treatment and / or prevention of chronic musculoskeletal pain, including CLBP, CNSLBP, osteoarthritis and / or other chronic musculoskeletal pain conditions as disclosed herein, the method comprising administering to a patient in need thereof an effective amount of the composition for use or pharmaceutical formulation for use described herein. In the present invention it is even more preferred that the invention provides a method for treatment and / or prevention of chronic musculoskeletal pain, including CLBP, CNSLBP, osteoarthritis and / or other chronic musculoskeletal pain conditions, the method comprising administering to a patient in need thereof an effective amount of the composition for use or pharmaceutical formulation for use described herein. The method disclosed herein may comprise administering more than one composition for use or pharmaceutical formulation for use of the present invention to the patient in need thereof. The method may also comprise administering an active agent other than the composition for use or pharmaceutical formulation for use of the present invention. This active agent may be administered simultaneously or consecutively with the composition for use or pharmaceutical formulation for use of the present invention. The composition for use or pharmaceutical formulation for use as described herein may be administered before or after the other active agent. Further, the route of administration may be the same or different.In the context of the present invention, the term “response rate” refers to the proportion of patients who have a response to therapy, i.e. who experience pain relief. Pain response rates, particularly the 30% response rate and the 50% response rate, describe thepercentage of people treated and reporting a reduction of pain of 30% or 50%, respectively, compared to baseline pain. Pain can be assessed with any suitable scoring system including but not limited to a Numerical Rating Scale (NRS), a Verbal Rating Scale, Pain Drawing and the McGill Pain Questionnaire (Haefeli and Elfering 2006, Eur Spine J 2006, Review, 15(S1 ), 17-24). From the assessed pain scores of multiple patients the respective response rates (e.g., the percentage of 30% and 50% responders) can then easily be calculated. In the exemplary embodiments of the appended Examples, pain is assessed according to a 11 -point NRS, in which patients are asked to circle the number between 0 (no pain) and 11 (extreme pain) that fits best to their pain intensity.In the context of the present invention, the term “chronic low back pain” or “CLBP” is understood as the pain in the area of the posterior aspect of the body from the lower margin of the 12th ribs to the lower gluteal folds with or without pain referred into one or both lower limbs that persists for 12 weeks or longer. Pain persists with varied intensity from mild to severe. The pathology can be further classified based on the cause. In case of an identifiable somatic cause whose targeted therapy may positively influence the course of the disease (e.g., fracture, disc herniation, osteoporosis) this is referred to as specific low back pain. If a cause for the low back pain cannot be found with simple, clinical methods, it is regarded as “chronic non-specific low back pain” or “CNSLBP”, which concerns around 90% of cases. Chronic low back pain is a complex mixed pain concept with two different pain components: nociceptive and neuropathic pain. Nociceptive pain is the result of inflammatory processes, tissue damage, or excess strain on muscles, joints, tendons and / or ligaments, fasciae, ligaments or tendons, which activates local nociceptors. In contrast, neuropathic pain is caused by compression and / or damage to nerve fibers.In the context of the present invention, the term “osteoarthritis” is understood as a painful degenerative joint disease. It is the most common type of arthritis and is more common in older people. It is characterized by the gradual wearing down of cartilage within the joints, leading to pain, stiffness, limited mobility, and often swelling. While it can affect any joint in the body, it most frequently impacts the knees, hips, spine, and hands.In the context of the present invention, the term “other chronic musculoskeletal pain conditions” refers to all other chronic musculoskeletal pain conditions characterized bychronic pain in muscles, bones, joints, tendons and / or ligaments and adjacent connective tissue despite CLBP, CNSLBP and osteoarthritis. Other chronic musculoskeletal conditions include, among others, conditions that affect: one or multiple body areas or systems, such as chronic back and neck pain or widespread pain conditions (e.g., fibromyalgia) joints, tendons and / or ligaments, such as rheumatoid arthritis, psoriatic arthritis, gout, spondylarthritis bones, such as osteoporosis and, osteopenia muscles, such as sarcopeniaAs used herein, the terms "treating", "treatment" and the like are understood as affecting a subject, tissue or cell to obtain a desired pharmacological and / or physiological effect in terms of a partial or complete cure of a disease or associated symptoms. The terms "preventing", "prevention" and the like are understood as prophylactic treatment of the subject in terms of completely or partially preventing the occurrence, arresting the development or reducing the severity of a disease or associated symptoms. The term "subject" as used herein refers to a mammal, preferably a human.The composition for use and pharmaceutical formulation for use as disclosed herein, which are particularly useful in medicine as described above, may be administered locally or systematically. They may be administered by any suitable means, including oral, oromucosal (including buccal and sublingual), rectal, intra-nasal, topical (including dermal), vaginal or parenteral (including intramuscular, subcutaneous and intravenous) administration or in a form suitable for administration by inhalation or insufflation. In the present invention, it is preferred that the composition for use or pharmaceutical formulation for use as disclosed herein is orally applied. The composition for use or pharmaceutical formulation for use as disclosed herein may be in any suitable form including in aerosol, liquid or powder form without limitation, and may be presented in any suitable design such as in liquids, lotions, ampoules, sprays or tablets. Such suitable forms and administration designs are known to the skilled person and are furthermore exemplarily listed in the continuing detailed description without limitation. The skilled person will appreciate that the composition for use or pharmaceutical formulation for use as disclosed herein may comprise further ingredients such as acceptable carriers, diluents, adjuvants, excipients and others, or any combination thereof, which depend on the form and route of administration and are exemplarily provided in the continuingdetailed description. The skilled person will appreciate that the composition for use or pharmaceutical formulation for use of the present invention may be prepared by any means known in the art. It may be employed as pressurised preparations, or as solids or semi-solids such as tablets or filled capsules, or liquids for external or internal use such as solutions, suspensions, emulsions, elixirs, or capsules filled with the same, all for oral use, in the form of suppositories for rectal administration, in the form of aerosols or in the form of sterile injectable solutions for parenteral (including subcutaneous) use. Compositions / pharmaceutical formulations for use for parenteral administration include sterile aqueous or non-aqueous solutions, suspensions and emulsions. Examples of nonaqueous solvents are propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable organic esters such as ethyl oleate. Examples of suitable pharmaceutical carriers are well-known in the art and include both solid and liquid carriers. Solid carriers may be in the form of powders, tablets, pills, capsules, cachets, suppositories, and dispensable granules. A solid carrier can be one or more substances which may also act as diluents, flavouring agents, solubilizes, lubricants, suspending agents, binders, tablet disintegrating agents, or an encapsulating material. Liquid carriers include water, alcoholic / aqueous solutions, emulsions or suspensions, including saline and buffered media, various types of wetting agents, or others. Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils. Intravenous vehicles include fluid and nutrient replenishes, electrolyte replenishers (such as those based on Ringer's dextrose) and the like. In addition, the composition for use or pharmaceutical formulation for use of the present invention might comprise proteinaceous carriers, like, e.g., serum albumin or immunoglobulins, preferably of human origin and may also comprise, optionally, suitable formulations stabilizers, and / or excipients. Preservatives and other additives may also be present such as, for example, antimicrobials, antioxidants, chelating agents, and inert gases and the like. As described in the foregoing description, the composition for use as described herein may be mixed with one or more naturally derived oils (e.g. an essential oil) or waxes to provide the pharmaceutical formulation for use of the present invention.The composition for use or pharmaceutical formulation for use as described herein may be presented in any suitable form including, without limitation, unit dose form in ampoules, pre-filled syringes, small volume infusion, multi-dose containers, droppers, pipettes, sprays, ointments, creams, lotions, or as a transdermal patch. Dosage unit form as used herein refers to physically discrete units suited as unitary dosages for the subjects to betreated. It is also envisaged that the composition for use or pharmaceutical formulation for use as described herein may be in powder form, obtained by aseptic isolation of sterile solid, for constitution with a suitable vehicle, e.g. sterile, pyrogen-free water, before use. The composition for use or pharmaceutical formulation for use as described herein may preferably be orally administered, for example, with an inert diluent or with an assimilable edible carrier, enclosed in hard or soft shell gelatine capsule, compressed into ingestible tablets or buccal tablets, lozenges, troches, capsules, elixirs, suspensions, syrups, wafers, sprays, chewing gums, mouthwashes and the like, or incorporated directly into the food of the diet. Such composition for use or pharmaceutical formulations for use for oral administration may also contain additional components such as carriers, colorants, stabilizers, buffers, coatings, binders, excipients, disintegrating agents, sweetening agents and / or flavouring agents and the like. Administration to the respiratory tract may also be achieved by means of an aerosol composition for use or pharmaceutical formulation for use in which the active ingredient is provided in a pressurised pack with a suitable propellant such as a chlorofluorocarbon (CFC), or other suitable gases. In the exemplary embodiments of the appended Examples, the pharmaceutical formulation is filled in amber glass bottles and administered orally via a dosing syringe.The skilled person will understand that the composition for use or pharmaceutical formulation for use as described herein is formulated so as to be suitable for application to a patient, to be compatible with the actives present in the composition / pharmaceutical formulation and to not cause any unreasonable safety or toxicity concerns. As such, the composition for use or pharmaceutical formulation for use as described herein may be subjected to further treatment, e.g. pH adjustment.The composition for use or pharmaceutical formulation for use described herein can be administered to the subject by any suitable means. The administration may be performed by the attending physician, a different medical professional (e.g. nurse), a person without medical knowledge (e.g. friend or family without a medical background), or by selfadministration. Preferably, the administration is performed by self-administration. In the exemplary embodiments of the appended Examples, the administration is performed by self-administration.The composition for use or pharmaceutical formulation for use described herein can be administered to the subject at any suitable dose. The dosage regimen will be determinedby the attending physician and clinical factors. As is well known in the medical arts, dosages for any one patient depend upon many factors, including the patient’s size, body surface area, age, the particular compound to be administered, sex, time and route of administration, general health, and other drugs being administered concurrently. As a matter of example, a dosage regimen may be determined in a titration phase based on experience / sensation of pain and adverse events. The duration of the titration phase may be from between 1 week to 12 weeks. Preferably, the duration of the titration phase is from between 2 to 6 weeks. Most preferably, the duration of the titration phase is 3 weeks. At the start of the titration phase, the subject, preferably a human patient, may receive 2.5 mg THC by administering a corresponding amount of the composition for use or pharmaceutical formulation for use described herein on day 1 in the evening. In case the subject does not experience adverse effects but still experiences pain, the subject may receive the same dose of 2.5 mg THC for further two days in the evening. In case the subject does not experience adverse effects but still experiences pain on day 3, the dose to be administered on day 4 in the evening is increased to a dose of 5 mg THC e.g. by administering a corresponding amount of the composition for use or pharmaceutical formulation for use described herein. Further, on day 4, the subject may start to receive an additional dose of 2.5 mg THC in the morning by administering a corresponding amount of the composition for use or pharmaceutical formulation for use described herein. The subject may receive the same dose of 5 mg THC in the evening and 2.5 mg in the morning for further two days. In case the subject does not experience adverse effects but still experiences pain on day 6, the dose to be administered on day 7 in the evening is increased to a dose of 7.5 mg THC e.g. by administering a corresponding amount of the composition for use or pharmaceutical formulation for use described herein. Further, on day 7, the subject may increase the additional dose in the morning to 5 mg THC by administering a corresponding amount of the composition for use or pharmaceutical formulation for use described herein. In case the subject experiences adverse effects, e.g. on day 3, the dose to be administered on day 4 in the evening is decreased to a dose of 2.5 mg THC. Then the subject may receive the same dose of 2.5 mg THC for further two days in the evening. In case the subject does not experience adverse effects and does not experience pain, the dose may be kept constant and is not increased or decreased. In the exemplary embodiments of the appended Examples, the patientindividual optimal dose is determined by self-titration in a 3-week titration phase. The selftitration starts with an initial daily dose of 2.5 mg THC in the evening and depending on the pain response and the occurrence of adverse events, the patient increases the dosein steps of 2.5 mg THC every three days until they experience sufficient pain relief, intolerable side effects, or reach the maximum daily dose of 32.5 mg THC. After completion of the titration phase, the dose may be adjusted as needed. However, a single dose may not exceed 20 mg THC and the daily dose may not exceed 32.5 mg THC.It is envisaged that the composition for use or pharmaceutical formulation for use of the invention may comprise, in addition to the composition for use of the invention, further biologically active agents depending on the intended use of the composition or pharmaceutical formulation. Any suitable active agent may be used, provided that the activity of the active agents and / or the composition / pharmaceutical formulation for use of the invention is not diminished when combined. Exemplarily, such additional active agents may be anti-inflammatory agents such as the commercially available drugs Aspirin®, Ibuprofen, Naproxen, Celecoxib or Diclofenac. Further, the invention envisages the co-administration protocols with other compounds, e.g. commercially available inflammatory agents such as those mentioned above or cotreatment with radiotherapeutic, chemotherapeutic, radionuclide or hormone treatments.The composition for use or pharmaceutical formulation for use described herein can be administered in the dose determined in the titration phase in a subsequent treatment phase, which can have any suitable duration. The duration of the treatment phase will be determined by the attending physician and clinical factors. As is well known in the medical arts, the duration of the treatment phase may depend upon many factors, including the particular compound to be administered, how the patient tolerates the particular compound, the general health, and other drugs being administered concurrently. The duration of the treatment phase may be from between 1 week to 60 weeks. Preferably, the duration of the treatment phase is from between 4 weeks to 52 weeks. More preferably, the duration of the treatment phase is from between 12 to 36 weeks. Most preferably, the duration of the treatment phase is 26 weeks. In another embodiment, the duration of the treatment phase may be from between 12 months to 48 months. Accordingly, the duration of the treatment phase may be 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, or 48 months. In yet another embodiment, the duration of the treatment phase may be from between 2 years to 10 years. Accordingly, the duration of the treatment phase may be 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, or 10 years. Absent any adverse events and if long-term efficacy is maintained, the duration of the treatment phase preferably is unlimited. In one exemplary embodiment of the appended Examples, the duration of thetreatment phase is 4 weeks. In another exemplary embodiment of the appended Examples, the duration of the treatment phase is 12 weeks. In yet another exemplary embodiment of the appended Examples, the duration of the treatment phase is 24 weeks. In yet another exemplary embodiment of the appended Examples, the duration of the treatment phase is 26 weeks. In yet another exemplary embodiment of the appended Examples, the duration of the treatment phase is 52 weeks.During the treatment phase, the composition for use or pharmaceutical formulation for use described herein can be administered to the subject any suitable frequency. The frequency of administration may be from between 4 times a day to 1 time every 2 days. Preferably, the frequency of administration is from 3 times a day to 1 time a day. Most preferably, the frequency of administration is 2 times a day. In the exemplary embodiments of the appended Examples, the frequency of administration is 2 times a day as determined by self-titration.The treatment phase may optionally be preceded by a run-in phase. A run-in phase is a period between the recruitment and randomization phases of a clinical trial in which all participants receive the same treatment, which may be active treatment, a placebo or no treatment at all. The duration of the run-in phase may be from between 1 week to 8 weeks. Accordingly, the duration of the run-in phase may be 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, or 8 weeks. Preferably, the duration of the run-in phase is 2 weeks. In one exemplary embodiment of the appended Examples, the duration of the run- in phase is 1 week. In another exemplary embodiment of the appended Examples, the duration of the run-in phase is 2 weeks.The treatment phase may optionally be succeeded by a wash-out phase in which the administration of the composition for use or pharmaceutical formulation for use described herein is withdrawn so that its effects disappear and the subject’s characteristics return to their baseline state and potential adverse events resulting from withdrawal effects can be tracked and analyzed. The duration of the wash-out phase may be from between 1 week to 8 weeks. Accordingly, the duration of the wash-out phase may be 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, or 8 weeks. Preferably, the duration of the wash-out phase is 2 weeks. In one exemplary embodiment of the appended Examples, the duration of the wash-out phase is 2 weeks.In one exemplary embodiment of the appended Examples, a 1-week run-in phase is followed by a 3-week titration phase, which is followed by a 12-week treatment phase. In another exemplary embodiment of the appended Examples, a 3-week titration phase is followed by a 26-week treatment phase. In another exemplary embodiment of the appended Examples, a 3-week titration phase is followed by a 52-week treatment phase. In yet another exemplary embodiment of the appended Examples, a 4-week treatment phase is followed by a 2-week wash-out phase. In yet another exemplary embodiment of the appended Examples, a 2-week run-in phase is followed by a 3-week titration phase, followed by a 24-week treatment phase, followed by a 2-week wash-out phase.The present invention further relates to a kit comprising component A) the composition for use of the invention and component B) a carrier oil. The carrier oil comprised in the kit as described herein is preferably refined and of pharmaceutical grade and may be provided in a suitable quantity to produce a desired amount of the product when mixed with the composition of the invention. Such carrier oil may be a naturally derived oil (e.g. an essential oil) or one or more waxes or any combination thereof. Suitable naturally derived oils and waxes are known to the skilled person and are furthermore described herein. Any carrier oil which may be used or is particularly useful in the context of the composition for use of the invention or the pharmaceutical formulation for use of the invention, is applicable in the context of the kit of the invention.In the context of the invention, sesame oil may be used as preferred carrier oil providing component B. In the present invention, it is preferred that component A as described herein comprises THC in an amount of 5% by weight of component A, alpha-bisabolol in an amount of at least 0.017% by weight of component A, preferably of between 0.017% and 0.031 % by weight of component A, guaiol in an amount of at least 0.025% by weight of component A, preferably of between 0.025% and 0.046% by weight of component A, beta-caryophyllene in an amount of at least 0.025% by weight of component A, preferably of between 0.025% and 0.047% by weight of component A, and at least one additional terpene selected from the group consisting of linalool in an amount of at least 0.004% by weight of component A, preferably of between 0.004% and 0.007% by weight of component A, alpha-humulene in an amount of at least 0.008% by weight of component A, preferably of between 0.008% and 0.014% by weight of component A, nerolidol in an amount of at least 0.004% by weight of component A, preferably of between 0.009% and 0.017%, caryophyllene oxide in an amount of at least 0.002% by weight of component A,preferably of between 0.003% and 0.005% by weight of component A, and limonene in an amount of at least 0.001 % by weight of component A, preferably of between 0.001 % and 0.002% by weight of component A.In the context of the present invention, component A as described herein preferably comprises THC in an amount of 5% by weight of component A, alpha-bisabolol in a THC / alpha-bisabolol ratio of more than 160:1 , preferably between 160:1 and 295:1 , guaiol in a THC / guaiol ratio of more than 105:1 , preferably between 105:1 and 200:1 , beta-caryophyllene in a THC / beta-caryophyllene ratio of more than 105:1 , preferably between 105:1 and 200:1 and at least one additional terpene selected from the group consisting of linalool in a THC / linalool ratio of between 450:1 and 1400:1 , more preferably of 500:1 and 1330:1 , alpha-humulene in a THC / alpha-humulene ratio of between 300:1 and 725: 1 , more preferably of 355:1 and 665:1 , nerolidol in a THC / nerolidol ratio of between 200:1 and 600:1 , more preferably of 270:1 and 535:1 , caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1000: 1 and 2150: 1 , preferably between 1090: 1 and 2080:1 , and limonene in a THC / limonene ratio of between 1650:1 and 5050:1 , preferably between 1700:1 and 4970:1.The kit as described herein further comprises instructions for use of the kit. Specifically, the kit instructs the user to combine component A and component B in a suitable ratio. In the context of the present invention, a suitable dilution ratio would be a component A / component B ratio of between 1 :1 and 1 :1.5. More preferably, the kit instructs the user to combine component A and component B in a component A / component B ratio of 1 :1.38. In the context of the present invention, the kit instructs the user to combine component A and component B in such way, that the product resulting from combining component A and component B comprises between 1 .0% and 2.5% THC. Preferably, the kit instructs the user to combine component A and component B in such way, that the product resulting from combining component A and component B comprises between 1.0% and 2.5% THC, alpha-bisabolol in a THC / alpha-bisabolol ratio of between 100:1 and 450:1 , preferably 160:1 and 295:1 , guaiol in a THC / guaiol ratio of between 50:1 and 250:1 , preferably 105:1 and 200:1 and / or beta-caryophyllene in a THC / beta- caryophyllene ratio of between 50: 1 and 250: 1 , preferably 105: 1 and 200: 1 and / or at least one additional terpene selected from the group consisting of linalool, alpha-humulene and nerolidol in a THC / linalool ratio of between 450:1 and 1400:1 , more preferably of 500:1 and 1330:1 , a THC / alpha-humulene ratio of between 300:1 and 725:1 , more preferablyof 355:1 and 665:1 , and a THC / nerolidol ratio of between 200:1 and 600:1 , more preferably of 270:1 and 535:1. More preferably, the kit instructs the user to combine component A and component B in such way, that the product resulting from combining component A and component B comprises 2.1 % THC, alpha-bisabolol in a THC / alpha- bisabolol ratio of more than 160:1 , guaiol in a THC / guaiol ratio of more than 105:1 , betacaryophyllene in a THC / beta-caryophyllene ratio of more than 105:1 and / or at least one additional terpene selected from the group consisting of linalool, alpha-humulene and nerolidol in a THC / linalool ratio of more than 715:1 , a THC / alpha-humulene ratio of more than 355:1 and a THC / nerolidol ratio of more than 270:1.Most preferably, in the context of the present invention, the kit instructs the user to combine component A and component B in such way, that the product resulting from combining component A and component B comprises 2.1 % THC, alpha-bisabolol in a THC / alpha-bisabolol ratio of between 160:1 and 295:1 , guaiol in a THC / guaiol ratio of between 105:1 and 200:1 , beta-caryophyllene in a THC / beta-caryophyllene ratio of between 105:1 and 200:1 and / or at least one additional terpene selected from the group consisting of linalool, alpha-humulene and nerolidol in a THC / linalool ratio of 500:1 and 1330:1 , a THC / alpha-humulene ratio of between 355:1 and 665:1 and a THC / nerolidol ratio of between 270:1 and 535:1.Correctly following the instructions for use of the kit, the resulting product provides the pharmaceutical composition for use of the invention. As such, the kit of the invention can be employed in a variety of applications referred to in the context of the composition for use and / or pharmaceutical formulation for use as disclosed herein. Specifically, the kit as described herein is particular useful in medicine. Furthermore, the kit as described herein is particular useful for the treatment and / or prevention of conditions / diseases associated with pain as described herein above, specifically CLBP, CNSLBP, osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles. Furthermore, the kit as described herein may be advantageously used, inter alia, for carrying out the method for treatment and / or prevention of conditions / diseases associated with chronic musculoskeletal pain as disclosed herein, specifically chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles.The kit for use of the invention may further comprise additional components for convenience of the user, such as a suitable container, preferably an amber glass flask, suitable dropper inserts / dropper inserts which allow more exact dosing and / or closing caps / sealing caps which may be childproof for safety reasons. Such additional components are preferably of pharmaceutical grade and / or sterile. Furthermore, parts of the kit of the invention can be packaged individually in vials or bottles or in combination in containers or multicontainer units.In the context of the present invention, the skilled person will understand that in the kit for use of the invention, as applicable to the composition for use of the present invention and the pharmaceutical formulation for use of the present invention, THC is comprised as main cannabinoid, but the optional presence of other cannabinoids including, without limitation, cannabidiol (CBD) is not excluded. As such, it is envisaged that the kit for use of the invention may further comprise a further cannabinoid preparation, e.g. an alcoholic solution comprising a cannabinoid other than THC as main cannabinoid, CBD being mentioned as preferred example (e.g. as commercially provided by 1x Cannabis Vollextrakt VERTANICAL CBD 50 solution, Vertanical GmbH, catalogue number: 16234579). The kit for use of the invention may then instruct the user to combine component A, component B and the additional cannabinoid preparation into one product.In the foregoing detailed description of the invention, a number of individual elements, characterizing features, techniques and / or steps are disclosed. It is readily recognized that each of these has benefit not only individually when considered or used alone, but also when considered and used in combination with one another. Accordingly, to avoid exceedingly repetitious and redundant passages, this description has refrained from reiterating every possible combination and permutation. Nevertheless, whether expressly recited or not, it is understood that such combinations are entirely within the scope of the presently disclosed subject matter.All technical and scientific terms used herein, unless otherwise defined, are intended to have the same meaning as commonly understood by one of ordinary skill in the art. Reference to techniques employed herein are intended to refer to the techniques as commonly understood in the art, including variations on those techniques or substitutions of equivalent techniques that would be apparent to one of skill in the art.The present invention is further described by reference to the following non-limiting figures and examples.The Figures show:Figure 1 : Inflammatory cytokine secretion of PBMC in dependence on single substances when compared to a mixture of those without PHA-stimulation. Figure1 shows the measured respective concentrations of a variety of cytokines depicted in the Figure at different concentrations of THC (A), alpha-bisabolol (B), guaiol (C) and a mixture of THC, alpha-bisabolol and guaiol (D) in non-PHA-stimulated control PBMCs.Figure 2: PHA-induced inflammatory cytokine secretion in dependence on single substances when compared to a mixture of those. Figure 2 shows the measured respective concentrations of a variety of cytokines depicted in the Figure at different concentrations of THC (A), alpha-bisabolol (B), guaiol (C) and a mixture of THC, alpha- bisabolol and guaiol (D) in PHA-stimulated PBMCs.Figure 3: Cytokine secretion when THC, alpha-bisabolol and guaiol are administered as single substances relative to a mixture of those. Figure 3 shows the calculated concentration-dependent relative differences in secretion of a variety of cytokines depicted in the Figure by PBMCs between the administration of THC, alpha- bisabolol and guaiol as single substances relative to a mixture of THC, alpha-bisabolol and guaiol. Calculation of the relative values is based on the experimental data shown in Figures 1 and 2, whereby PHA-induced inflammatory cytokine secretion has been normalized to non-PHA-stimulated control values.Figure 4: Percentage of 30% and 50% pain responders in the open-label phase B of the study VER-CLBP-001. Figure 4 shows the reported percentage of 30% and 50% pain responders in a European phase III study. 71.54% of the patients who already completed the open-label phase report a clinically relevant pain relief of at least 30% and 50.94% of at least 50% compared to baseline. The number of responders increases over the first 6 weeks and then remains relatively constant over time with a slight increase.The following Examples illustrate the invention:Example 1 Cytokine secretion of stimulated Peripheral Blood Mononuclear Cells (PBMCs)The following example demonstrates that anti-inflammatory activity is enhanced when THC, and the exemplary terpenes alpha-bisabolol and guaiol are administered in a combinatory treatment when compared to a treatment with either THC, alpha-bisabolol or guaiol alone.1.1 P BMC culturePBMCs of four different healthy donors of Caucasian ethnicity without any known diagnosis of autoimmune diseases were commercially obtained (Immunospot) and used in the experiment: PBMCs No. 1 (male, 24 years old, CTL, # HHU20210720, PBMCs No. 2 (female, 24 years old, CTL, # HHU20210722), PBMCs No. 3 (female, 44 years old, CTL, # HHU20210727) and PBMCs No. 4 (male, 20 years old, CTL, # HHU20210729). Cells of all four donors were pooled for the experiment.PBMCs were cultured in RPMI 1640 (PAN-Biotech, Cat# P04-16500) supplemented with 10% FBS. For the assays, pooled PBMCs were seeded at a concentration of 200.000 cells / well on 96 well plates and were immediately used for the assay. The test substances (as prepared in 1.2) were added, and after 30 min pre-incubation, 10 pg / ml (final) phytohemagglutinin L (PHA) (Roche, Cat# 11249738001 ) as pro-inflammatory stimulus or medium as control were added. After 48 h the plates were centrifugated and the supernatant was collected for the cytokine measurement, the remaining cells were used for the cell viability test.1 .2 Preparation of test substancesDronabinol (produced by Pharma Wernigerode GmbH; THC content: 95.37%), , alpha- bisabolol (Sigma, Cat# 14462) and guaiol (Cayman Chemicals, Cat# 23172) prepared in dimethylsulfoxide (DMSO, Carl Roth, Cat# 4720.2) were diluted in cell culture medium to obtain the final concentrations as shown in Tables 4 and 5. Each concentration for assayed single substances and the indicated combination of substances was tested in technical triplicates.As negative control, PBMCs were cultured in culture medium containing the same amount of the respective solvent that is also present in the samples (0.4% DMSO) to make sure that toxic observations resulted from the test items and not from the solvent. As positivecontrol, 10 pg / ml PHA was added to PBMCs in cell culture medium. Medium only was used as blank.1.2.1 Assa ved concentrations of test substancesTable 4: Assayed concentrations of test substances with PHA as pro-inflammatory stimulus.Table 5: Assayed concentrations of test substances without PHA as stimulus.1.3 Assay procedures1.3.1 Quantification of cytokinesQuantification of the cytokines IFN-y, IL-1J3, IL-2, IL-4, IL-6, IL-10, IL-13, IL-12p70, TNF- a, IL-5 and GM-CSF was performed by using V-Plex MSD kit (MSD, Cat# K151A9H-2) and MESO QuickPlex SQ 120MM system (Meso Scale Discovery). The human PBMCcells (200,000 cells) were mixed with the test items (except PHA) in the concentrations and combinations as indicated in Tables 4 and 5, and were incubated for 30 min at 37°C. Then, PHA or the respective volume of medium as control was added and incubated for 48 h. Afterwards, 200 l of supernatant was collected and frozen. 30 pl or less (depending on the dilution) of the supernatant was used for the cytokine quantification. Dilution of the collected supernatant might be required for correct cytokine measurement. The correct dilution will be established in the two test measurements of the cell supernatants with and without PHA stimulation.For the measurements, samples, calibrators (part of the V-Plex MSD kit) and controls were transferred to a special assay plate covered with capture antibodies that are able to bind the cytokines of interest from the samples. After incubating the plate for 2 h at room temperature, the detection antibodies were added and the plate was incubated for another 2 h at room temperature. Afterwards, the test plate was washed and reading buffer was added. The detection antibodies contain a special ruthenium tag (SULFOTAG™) and the reading buffer contains Tripropylamin (TPrA). Tripropylamine (TPrA) is oxidized at the electrode and generates the radical cation (TprA°+), which is quickly (halflife ~ 200 ps) deprotonated and forms the radical (TprA°). The radical and the radical cation react with the electrochemiluminescence phosphor (Ru(bpy)32+). The luminescent material in the excited state Ru2+* relaxes to the ground state and emits photons at 620 nm. The QuickPlex SQ 120MM (Meso Scale Discovery) uses a CCD camera to detect the light emission and to obtain images of the plate during reading. The obtained results were quantified using special software (MSD Discovery workbench) and calibration standards.1.3.2 Viability testingCellTiter-Glo® Luminescent Cell Viability Assay was used to quantify viable cells (Cell Viability Kit I, Promega, Cat# G7570). The test is based on quantification of the ATP present, which signals the amount of the metabolically active cells. The single reagent containing luciferin, which is converted into oxyluciferin in the presence of ATP and Mg2+, was be added to the cells, mixed for 2 min, stabilised for additional 10 min and afterwards the luminescence was measured by using Wallac 1420 Multilabel Counter (Perkin Elmer GmbH).1.3.3 Data analysisFor the dose-response relationship, absolute absorption (OD treated wells - background) were related to the negative (medium) control and relative viability values were plotted against the test item concentrations.1.4 ResultsFigure 3 shows the beneficial interaction of THC with the terpenes alpha-bisabolol and guaiol in terms of anti-inflammatory activity. To arrive at the depicted values presented in Figure 3, for each data point of the concentration of THC, alpha-bisabolol or guaiol, the respective cytokine secretion measured in the PHA-stimulated group was corrected by the cytokine secretion of the non-PHA-stimulated control. The respective experimental data of cytokine secretion in non-PHA-stimulated control PBMCs and PHA-stimulated PBMCs are shown in Figures 1 and 2. Those corrected values of the individual compounds THC, alpha-bisabolol or guaiol were set into relation to the corrected values of the respective mixture of THC, alpha-bisabolol and guaiol.As a matter of example, the calculation for the exemplary cytokine IL-2 shown in Figure 3 was accomplished by using the following equation:Relative difference[cIL-2, stimulatedcIL-2,non-stimulated]THc T [cIL-2, stimulatedcIL-2,non-stimulated]a-bjsabojoj[cIL-2, stimulated— cIL-2,non-stimulated]gUajoj[CIL— 2, stimulated “CIL-2,non-stimulated]THC+a-bisabolol+guaiolAs all tested cytokines are indicatory for an inflammatory reaction of the PBMC’s in response to PHA-induced stimulation, any decrease of cytokine secretion after administration of either THC, alpha-bisabolol or guaiol alone or of all three components in combination, when compared to the non-stimulated control, is indicative for an antiinflammatory activity. By virtue of the above-described equation, a direct comparison can be drawn between the anti-inflammatory activity of the single substances THC, alpha- bisabolol and guaiol and the respective mixture thereof. Any value higher than 1 implies that the cytokine secretion of the mixture (in the denominator) is less than the sum of cytokine secretion of the respective individual substances. In such case the anti-inflammatory activity of the mixture therefore outperforms the combined anti-inflammatory activity of the individual compounds.As evident from Figure 3, cytokine secretion is reduced when THC, alpha-bisabolol and guaiol are administered in combination compared to THC, alpha-bisabolol or guaiol alone. These results indicate that anti-inflammatory activity is enhanced when THC, alpha- bisabolol and guaiol are administered in a combinatory treatment in a THC / alpha- bisabolol ratio of between 100:1 and 450:1 , specifically between 160:1 and 295:1 , and / or a THC / guaiol ratio of between 50: 1 and 250: 1 , specifically between 105: 1 and 200: 1 . The Cannabis plant extract of the present invention comprises THC and the terpenes alpha- bisabolol and guaiol in the ratio as tested individually in the Examples. Thus, it is believed that a composition and pharmaceutical formulation of the invention which has the same individual effective components and THC / terpene ratio as the Cannabis extract disclosed in the present invention, are particularly effective in providing anti-inflammatory activity. Accordingly, the anti-inflammatory activity of alpha-bisabolol and guaiol is plausible to be enhanced by the presence of THC. These results render plausible that the composition and the pharmaceutical formulation of the invention have the superior effect of having an increased anti-inflammatory activity, which again supports pain relief efficacy in chronic pain, specifically chronic musculoskeletal pain indications, such as chronic low back pain and particularly osteoarthritis.Example 2 Stability of the compositionThe following example demonstrates that stability of THC in a plant extract can be increased by addition of a carrier oil such as sesame oil.2.1 Test substancesCannabis plant extract / Cannabis soft extract as obtainable by a Cannabis plant deposited by Vertanical GmbH by the Community Plant Variety Office with the application number A202104053 or as obtainable by the process as described in patent application EP22154007.3 (PCT / EP2023 / 052073) has been used for the experiment (Table 6). The aforementioned Cannabis plant extract was optionally further processed by distillation and / or by further dilution. The distillate was produced from the Cannabis plant extract by short path distillation. Cannabinoids and terpenes present in the extract are evaporatedand collected as a distillate. Heavier material like chlorophyll, sugars, salts and fats are unable to evaporate and remained as residue. Dilution of the Cannabis plant extract was performed by adjusting the extract to a THC content of either 10% or 5% by weight by adding the respective volume of either ethanol or sesame oil.Table 6: Characteristics of the Cannabis plant extract / Cannabis soft extract as obtainable by a Cannabis plant as deposited by the Community Plant Variety Office with the application number A202104053 after evaporation and decarboxylation or as obtainable by the process as described in patent application EP22154007.3 (PCT / EP2023 / 052073).2.2 ResultsTable 7: Stability of Cannabis plant extract, and Cannabis plant extract which has been further processed as described in the Table, after 14 days storage at the indicated temperature.As evident from Table 7, THC in Cannabis plant extract is relatively unstable at elevated temperatures of 50°C, showing a degradation of 15% of THC over 14 days of storage. Cannabis plant extract which has been diluted with ethanol to 10% or 5% THC is more stable at elevated temperatures compared to Cannabis plant extract not further processed, but still relatively unstable. Cannabis plant extract standardized to 5% THC by adding sesame oil remains stable over 2 weeks, even when stored at a very high temperature of 70°C.As shown in Tables 8 and 9, further studies proof the long-term stability of Cannabis plant extract standardized to 5% THC by adding sesame oil.Table 8: Stability of Cannabis plant extract in sesame oil after 0, 4, 8 or 12 weeks of storage at 40°C.Table 9: Stability of Cannabis plant extract in sesame oil after 2 years of storage at 25°C.These results show that the preferred composition of the invention comprising a Cannabis plant extract and sesame oil, e.g. preferably a Cannabis plant extract as defined in Table 6 diluted with sesame oil, has a superior technical effect of providing improved short- and long-term stability of cannabinoids such as THC.Example 3 Clinical data from on-going European phase 3 trialA pharmaceutical formulation for use according to the invention is currently under clinical investigation in Europe and is also referred to herein as the investigational medicinal product (IMP). An ongoing European phase 3 study is investigating the efficacy and safety of the pharmaceutical formulation of the invention (the IMP) in the treatment of patients with chronic non-specific low back pain (Study code: VER-CLBP-001 ; ClinicalTrials.gov Identifier: NCT04940741 ).The pharmaceutical formulation of the invention (the IMP) comprises the composition of the invention (a Cannabis extract standardized to a THC content of 5% by weight) and is diluted to a THC content of 2.1 % THC by weight of the formulation by adding sesame oil. Additional components of the pharmaceutical formulation of the invention (the IMP) fall within the scope of Table 2. The specific composition of the batches which have been used in the clinical trial phase B (open-label treatment, 3-week titration, 26-week treatment; investigation of long-term safety) are provided with Table 3. The pharmaceutical formulation of the invention (the IMP) is filled in amber glass bottles and administered orally via a dosing syringe, which is self-administered by the patient orally twice daily, once in the morning (between awakening and 12 o'clock) and once in the evening (between 4 pm and bedtime). The patient-individual optimal dose is determined by self-titration. The self-titration starts with an initial daily dose of 2.5 mg THC in the evening and depending on the pain response and the occurrence of adverse events, the patient increased the dose in steps of 2.5 mg THC every three days until he experiences sufficient pain relief, or intolerable side effects or reaches the maximum daily dose of 32.5 mg THC. After completion of the titration phase, the dose can be adjusted as needed. However, a single dose might not exceed 20 mg THC and the daily dose might not exceed 32.5 mg THC.3.1 Study DesignThe on-going study is divided into different phases investigating the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of the pharmaceutical formulation of the invention (the IMP) in the treatment of patients with chronic non-specific low back pain. The study is divided into 4 phases (A, B, C and D):In study phase A, following a 1-week run-in phase for the collection of baseline data, 808 eligible patients are randomized to receive placebo or a pharmaceutical formulation of the invention (the IMP) and undergo a 3-weeks titration phase to find their patient individual optimal dose. Subsequently, patients enter a 12-week treatment phase. The objective of study phase A is to compare the efficacy and safety of the pharmaceutical formulation of the invention (the IMP) to placebo.Approximately 500 patients completing study phase A, enter study phase B which includes a 3-week open-label titration period followed by a 6-month open-label treatment period. In the study phase B, all patients are treated with the pharmaceutical formulation of the invention (the IMP). In study phase B, both efficacy and safety parameters are assessed. First study results are available from this open-label phase. 518 patients have already been enrolled and treated.Approximately 170 patients completing study phase B, enter into study phase C and 120 patients into study phase D. In study phase C, patients are treated open-label for further 6-month to assess safety and efficacy after long-term treatment (at least 1 year of active treatment). In study phase D, patients are randomized to receive placebo or the pharmaceutical formulation of the invention (the IMP) to assess maintenance of efficacy.3.1.1 Inclusion and exclusion criteriaInclusion criteria of patients into the study were:- Male and female patients (18 years and older).- Chronic (for at least three months) non-specific pain in the lower back (between the lower ribcage and the gluteal folds).- Pain intensity on average at least 4 points on an 11 -point NRS (one month before the start of the study).- Patients with indicated drug treatment (Drug treatment is indicated if analgesic drug therapy is considered supportive for the realization of activating measures, or if the patient has unbearable functional disabilities as a result of the pain, despite regularly performing these measures) where previous optimized treatments (treatment is considered optimized when a further increased drug dose is unsuitable from a medical perspective considering side effects and / or it is not expected that a higher drug dose would result in a further advantage in terms of efficacy) with non-opioid analgesicshave not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.- Willingness of both men and women to use a reliable method of contraception during study participation and for three months after taking the last dose of the pharmaceutical formulation of the invention (the IMP).- Signed patient information and informed consent form is available.- Understanding of the German language, compliance and ability to give consent.- The patient has understood the instructions to avoid changes in lifestyle and dietary habits.- The patient has understood the principle of the patient diary and gives their consent to keep it as instructed.Additional inclusion criteria for phase A were:- Mean value of the pain intensity in the morning of the 7 days before visit A2 (study week -1 ) must be at least 4 points on an 11 -point NRS. The last 7 pain intensity entries in the patient diary before visit A2 are used for the calculation (there must be at least 5 pain intensity readings in the morning from study week -1 ).- Willingness not to take any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study phase A (except rescue medication).- Willingness to continue a current non-drug therapy unchanged as planned during participation in phase A.Additional inclusion criteria for phase B were:- Previous and complete participation in phase A until and including Visit A6.- Patient wishes to participate voluntarily in the long-term study.- From the investigator's point of view, further participation is considered medically safe.- Willingness not to take any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during the last three weeks of study phase B (except rescue medication).Additional inclusion criteria for phase C were:- Previous and complete participation in phase B until and including the last visit in phase B (Visit B10).- Patient wishes to participate voluntarily in the long-term study.- From the investigator's point of view, further participation is considered medically safe.Additional inclusion criteria for phase D were:- Previous and complete participation in phase B until and including the last visit in phase B (Visit B10).- Patient has experienced a pain score improvement in the morning of at least 30% in treatment phase B (mean value of the pain intensity in the morning of study week 43 compared to the mean value of the pain intensity in the morning of the seven days before visit A2 (study week -1 ), there must be at least four values from study week 43 and five values from study week -1 )- Patient wishes to participate voluntarily in the long-term study.- From the investigator's point of view, further participation is considered medically safe.- Willingness not to take any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study Phase D (except rescue medication).- Willingness to continue a current non-drug therapy unchanged as planned during study participation in phase D.- Patient has taken the study product on at least 5 of 7 days in study week 43 (daily dose at least 1 n) and documented the intake of the study product in the patient diary.Criteria for exclusion of patients from the study were:- Professional groups for which the ability to operate machinery and drive vehicles is the primary activity (including truck, bus and forklift drivers, pilots).- Alcohol / drug / medication abuse and previous or current intake of methadone in the patient’s medical history or suspected by the investigator.- Intake of analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within seven days prior to the start of the study.- Taking cannabis-based medicinal products within 30 days prior to the start of the study.- HIV, dementia (which impairs the assessment of symptoms)- Severe forms of the following diseases: Anaemia, hematological / autoimmune / endocrinal / renal / hepatic / respiratory / cardiovascular or gastrointestinal diseases, symptomatic peripheral vascular diseases.- Cardiovascular event in the last three months, poorly managed high blood pressure, untreated hypothyroidism, patients with Crigler-Najjar syndrome or Rotor syndrome, surgery within the past two months.- Severe mental illnesses (e.g., psychosis, schizophrenia, bipolar disorder) at present or in the past, severe depression at present or in the past that is not due to the chronicnon-specific low back pain, or individuals at risk of suicide (examined using the MINI questionnaire: when at least one module is fulfilled).- Severe mental illness (psychosis, schizophrenia, bipolar disorder, severe depression, anxiety disorder) at present or in the past in a first-degree relative (parents and children); suicide in a first-degree relative (parents and children)- Patients with an active cancer or tumor-related pain or strong pain due to physical injuries.- Other painful comorbidities, excluding low back pain, that could interfere with the patient's evaluation during the study or the assessment of pain.- Well-known strong adverse events in connection with cannabis consumption before the start of the study.- Known allergy to cannabis and / or sesame seeds and products derived from them.- Known hypersensitivity to the ingredients of the rescue medication.- Planned blood donation, planned sperm or egg donation, planned freezing of eggs or sperm.- Pregnancy, breastfeeding, desire to have children (within the next 20 months).- Participation in another clinical interventional trial within the past 30 days before the start of the study.- Inability to give consent, care dependency, patient has a legal guardian / caregiver, or is immobile.- The patient is in need of special protection (e.g., incarcerated; institutionalized by a court or judicial authority; in a dependent or employment relationship with the sponsor, an external service provider of the sponsor (who is involved in the study conduct), the investigator, or the study site).An additional exclusion criterium for phase A was:- In the case of a current non-drug therapy (e.g., physical or behavioral therapy, acupuncture, massage, thermotherapy), which significantly modulates the perception of pain, it was not maintained unchanged for at least eight weeks prior to study participation in phase A.Additional exclusion criteria for phase D were:- Intake of additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within 21 days prior to the start of study phase D (except rescue medication).- In the case of a current non-drug therapy (e.g., physical or behavioral therapy, acupuncture, massage, thermotherapy) that significantly modulates the perception of pain, it was not maintained unchanged for at least nine weeks prior to the start of study phase D.3.2 Results3.2. 1 EfficacyFigure 4 shows the reported percentage of 30% and 50% pain responders in the 6-month open-label phase (study phase B) of the European phase III clinical trial based on the daily patient reported NRS pain scores compared to baseline. 71.54% of the patients who already completed the open-label phase report a clinically relevant pain relief of at least 30% and 50.94% of at least 50% compared to baseline. The number of responders increased over the first 6 weeks and then remained relatively constant over time with a slight increase. Accordingly, a significant number of patients treated with a pharmaceutical formulation of the invention (the IMP) could achieve a clinically relevant pain reduction within the proposed dose range. In addition, the data reported show that the 30% response rate and 50% response rate for patients suffering from CNSLBP treated with a pharmaceutical formulation of the invention (the IMP) is on average 31 % and 26% higher, respectively, compared to previously reported response rates for treatment of CNSLBP with opioids (Figure 4 and Table 10).Table 10: 30% response rates and 50% response rates of patients taking the pharmaceutical formulation of the invention (the IMP) at the end of the open-label study phase compared with response rate data for opioid therapy as previously reported:3.2.2 Safety ProfileAdverse reactions seen in response to treatment with the pharmaceutical formulation of the invention (the IMP) in the on-going European phase III study included typical THC associated side effects such as dizziness, headache, somnolence, nausea, dry mouth, and diarrhea. Most of the adverse reactions occurred during the initial titration phase and were mild to moderate in intensity. In general, adverse reactions resolved quickly and tolerance to adverse events developed over a few days.3.2.3 Abuse-related adverse eventsIn general, the potential for abuse and dependency of orally taken THC-containing drugs such as Marinol® and Sativex® is known to be very low. Recreational Cannabis users do not value the effects of orally taken THC-containing drugs because the onset of action is very slow, and gradual compared to smoked Cannabis with a significantly lower maximum plasma concentration (Cmax of about 15 ng / ml after intake of a high dose of a pharmaceutical formulation of the invention (the IMP) compared to about 150 ng / ml after smoking) and the effects are harder to control.To evaluate the potential for abuse and dependency as well as withdrawal symptoms of a pharmaceutical formulation of the invention (the IMP), the following assessment instruments were used in acquiring the data of the on-going phase 3 trial:1. The occurrence of adverse events was queried daily in the eDiary. A special focus lied on the evaluation of adverse events that could be indicative for abuse. Especially, the presence of a euphoria-like response was considered a key observation in the clinical assessment of the abuse potential of the pharmaceutical formulation of the invention (the IMP). In addition to euphoria, other MedDRA preferred terms that may provide abuse-related information, including terms like elevated mood and feeling drunk were also evaluated.2. The Cannabis Withdrawal Scale (CWS), a 19-item instrument, was used to measure both the intensity of Cannabis withdrawal symptoms and the negative impact of symptoms on daily activities in the wash-out phase (Allsop, D. et al., Drug Ale Dep. 2011 ;119(1 -2):123-129). The individual items on the CWS include typical withdrawal symptoms that have been described in the literature after withdrawal of Cannabis. The intensity and impact on daily activities were measured using a 10-point Likert scale (from 0 = not at all to 10 = extremely). Both sum scores for the 19-item instrument were in the range of 0 to 190.3. The Addiction Behaviors Checklist (ABC), a 20-item instrument with dichotomous response scoring, was used to track behaviors characteristic of addiction related to narcotic analgesics (Wu, S.M. et al., J Pain Symptom Manage. 2006 Oct; 32(4): 342- 351 ). The items focus on observable behaviors noted both during and between visits by the investigator. The behaviors tracked in the ABC reflect those suggested in the consensus document by the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20.As described herein above, very common adverse events of using THC-containing drugs include dizziness, headache, and somnolence. However, in the absence of a euphorialike response, these effects are not indicative for an increased abuse potential. As shown in Table 11 , only 1 out of 647 patients has reported euphoric mood / elevated mood and only 2 patients reported a feeling of being drunk. Other reported adverse events that may be related to abuse were reported in low frequencies and are rather unappealing for drug abusers. Overall, these data indicate that a pharmaceutical formulation of the invention (the IMP) has a very low abuse potential, if at all.Table 11: MedDRA Preferred Terms, which may provide abuse-related information about a pharmaceutical formulation of the present invention (the IMP).3.2.4 Cannabis withdrawal symptomsAll patients who have completed the treatment period in phase D (randomized, doubleblind placebo-controlled, 4-week treatment; investigation of the maintenance of efficacy of the pharmaceutical formulation of the invention (the IMP) compared to placebo), enter a 2-week wash-out period. In the wash-out period, patients rated their withdrawal symptoms daily in the eDiary on the CWS. Based on their sum score (range of 0-190) for symptom intensity and negative impact on daily activity, patients have been divided into 3 groups:1. no / mild intensity and / or impact on activity = sum score < 632. moderate intensity and / or impact on activity = sum score > 63 and < 1263. severe intensity and / or impact on activity = sum score > 126.Table 12 shows the number of patients per group. Only one patient reported withdrawal symptoms of a moderate intensity and a moderate to severe negative impact on daily activity. All other patients reported no or only withdrawal symptoms of mild intensity and no or only mild impact on daily activity.Table 12: Cannabis withdrawal scale: Number of patients per category (No / mild: Score < 63, moderate: Score < 126, severe: Score > 126) for symptom intensity and negative impact on daily activity are shown for the wash-out period of study phase D. The symptoms marked with an asterisk * were all reported by the same patient.3.2.5 Potential of addictionThroughout the study, the investigators assessed the addiction potential using the ABC questionnaire at each study visit from the beginning of the titration period in Phase A (randomized, double-blind placebo-controlled, 3-week titration, 12-week treatment; investigation of the efficacy and safety of the pharmaceutical formulation of the invention (the IMP) compared to placebo). Table 14 shows the number of patients for whom the investigator answered questions from the ABC questionnaire with "yes" for each question. Most frequently, the investigators reported that their patient had a minimal / inadequate pain relief in study phase A. However, this is probably related to the circumstance that 50% of the patients in study phase A have been randomized to placebo. Accordingly, the investigators did not report minimal / inadequate relief for any patient at the end of the open-label study phase B. All other questions were answered only very occasionally with “yes” and do not indicate an increased addiction potential. Table 13 shows the number of patients per study visit, for whom an investigator has answered 1 , 2, 3 or 4 of 20 questions of the addiction behaviour checklist with “yes”. Only for three patients and only at four study visits, a physician has answered more than 2 questions with “yes”. However, the investigator reported that 2 patients had minimal / inadequate relief from narcotic analgesic and used more of the pharmaceutical formulation of the invention (the IMP) than allowed,which could also be the result of randomization to placebo. Overall, these data indicate that a pharmaceutical formulation of the invention (the IMP) has a very low addiction potential, if at all.Table 13: Number of patients, for whom the investigator has answered 1 , 2, 3 or 4 questions of the addiction behaviour checklist with “yes” per study visit.Overall, the absence of a euphoria-like response indicates that a pharmaceutical formulation of the invention (the IMP) has a very low abuse potential, if at all. In addition, a pharmaceutical formulation for use according to the present invention has also a very low addiction potential as measured by the addiction behaviour checklist. Only for a three patients, an investigator has answered more than 2 questions of the 20-item checklist with “yes”. Finally, besides one patient, all patients who have completed the treatment period in phase D reported no or only minor withdrawal symptoms. Accordingly, a pharmaceutical formulation of the invention (the IMP) provides the additional beneficial effect of low side effects compared to the use of opioids in the treatment of chronic pain, specifcally chronic musculoskeletal pain indications such as chronic low back pain patients.able 14: ABC Checklist: Number of patients for whom the physician answered questions from the addiction behaviour checklist with "yes".Example 4 European phase III clinical trial VER-CLBP-002This randomized, open-label, parallel-group European phase 3 study investigates the efficacy and safety of the pharmaceutical formulation of the invention (the IMP) for use according to the invention in the treatment of patients with chronic non-specific low back pain compared to opioids (Study code: VER-CLBP-002; ClinicalTrials.gov Identifier: NCT05610813).The pharmaceutical formulation of the invention (the IMP) comprises the composition of the invention (a Cannabis extract standardized to a THC content of 5% by weight) and is diluted to a THC content of 2.1 % THC by weight of the formulation by adding sesame oil. Additional components of the pharmaceutical formulation of the invention (the IMP) fall within the scope of Table 2. The pharmaceutical formulation of the invention (IMP) is filled in amber glass bottles and administered orally via a dosing syringe, which is self-administered by the patient orally twice daily, once in the morning (between awakening and 12 o'clock) and once in the evening (between 4 pm and bedtime). The patient-individual optimal dose is determined by self-titration. The self-titration starts with an initial daily dose of 2.5 mg THC in the evening and depending on the pain response and the occurrence of adverse events, the patient increased the dose in steps of 2.5 mg THC every three days until he experiences sufficient pain relief, or intolerable side effects or reaches the maximum daily dose of 32.5 mg THC. After completion of the titration phase, the dose can be adjusted as needed. However, a single dose might not exceed 20 mg THC and the daily dose might not exceed 32.5 mg THC.The comparative intervention is an opioid therapy (with an authorized and marketed opioid, ATC code N02A). The patient-specific selection of the marketed opioid (based on standard of care and provided for this study) is at the discretion of the investigator and made before randomization (at visit 1 ) to ensure that the outcome of the randomization does not influence the opioid selection. Preferably the opioid is administered orally with retarded release preparations. Titration and dosage are calculated according to the summary of product characteristics (SmPC) (maximum titration phase 3 weeks). The dosage and the chosen opioid (opioid rotation) can be adapted to the patient’s specific needs in the course of the study. Opioid therapy will only be continued if a clinically relevant reduction in pain and / orphysical impairment with absent or minor side effects have occurred in 12 weeks of treatment (evaluation at visit 6).4.1 Study DesignAt screening visit 1 , the investigator assesses the eligibility of patients for study inclusion according to the inclusion and exclusion criteria. In case of eligibility, the patients enter a 2- week run-in phase. In the last 7 days of the run-in phase (study week -1 ), the baseline low back pain intensity score is assessed. At visit 2, patients fulfilling randomization criteria are randomized to an open-label treatment with the pharmaceutical formulation of the invention (the IMP) or an opioid, which is determined individually for each patient based on standard of care by the investigator prior randomization at visit 1 . Patients will be randomized to the pharmaceutical formulation of the invention (the IMP) or opioid therapy in a 1 :1 ratio. During the subsequent 3-week titration phase, the pharmaceutical formulation of the invention (the IMP) or opioid analgesic will be titrated to the optimal dose according to titration scheme (pharmaceutical formulation of the invention (the IMP)) I SmPC (opioid analgesic). Subsequently, patients enter a 24-week treatment phase. After 12 weeks of treatment (at visit 6) the investigator assesses the treatment response of the pharmaceutical formulation of the invention (the IMP) or opioid therapy and eligibility to continue treatment. If the respective therapy is discontinued from investigator's point of view, the patients will be encouraged to remain within the study without the pharmaceutical formulation of the invention (the IMP) or opioid therapy and the investigator continues to treat the patient under consideration of available treatment options (except Cannab / s-based and opioid treatment). At the end of the treatment phase (visit 9), the pharmaceutical formulation of the invention (the IMP) is abruptly discontinued, and opioid therapy is tapered off over a period of max. 2 weeks according to the SmPC. The study is completed by visit 10 after the wash-out phase or a follow-up visit in case of early study termination. In this study 350 patients (planned) are randomized.4.1.1 Inclusion and exclusion criteriaCriteria for inclusion of patients into the study are:Male and female patients >18 years of age.Provision of informed consent form voluntarily signed and dated by the patient.For women of childbearing potential and men of reproductive potential: use of a reliable contraceptive method (Pearl index < 1 ) at least 1 month before the start of the study and willingness to use it during the study participation and 3 months after the last intake of the test or comparative intervention.Patient understands the local language and is willing and able to comply with scheduled visits, treatment plan, patient diary and other study related procedures throughout study participation.Chronic (for at least 3 months) non-specific pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). Non-specific pain refers to pain without a clear specific treatable cause.Patients with indicated drug treatment (drug treatment is indicated if analgesic drug therapy is considered supportive for the realization of activating measures), or if the patient has unbearable functional disabilities as a result of the pain, despite regularly performing these measures where previous optimized treatments (treatment is considered optimized when a further increased drug dose is unsuitable from a medical perspective considering side effects and / or it is not expected that a higher drug dose would result in a further advantage in terms of efficacy) with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.Low back pain intensity on average at least 4 points on an 11 -point Numeric Rating Scale in the last 4 weeks prior visit 1 .Ongoing non-drug pain therapy (physical or behavioral therapy) must have been stable for at least 2 weeks prior visit 1 and must be continued during the run-in phase.Ongoing additional analgesic treatment prior visit 1 must be continued during the run- in phase.Bowel Function Index total score of 28.8 or less at visit 1 .Criteria for exclusion of patients from the study are:Patients with a known history of alcohol / drug / medication abuse or dependency and previous or current use of methadoneEvidence of drugs of abuse or illegal drugs by urine drug test performed at visit 1 .Known intolerance or hypersensitivity to ingredients of rescue medication, opioid therapy (assigned by the investigator) and / or the pharmaceutical formulation of the invention (the IMP).Participation in another clinical interventional study within the last 30 days prior screening visit (visit 1 ).Occupational groups with primary activity of operating machinery and driving motor vehicles.Planned blood donation or planned donation or freezing of sperm or oocytes during study participation and 3 months after end of study participation.Pregnant or breastfeeding female patients.Patient is unable to provide written informed consent, in need for care, has a guardian / caretaker, is immobile, or is particularly vulnerable (e.g., imprisoned; institutionalised by a court or judicial authority; dependent or employed by the sponsor, an external service provider of the sponsor (involved in the conduct of the study), the investigator or the trial site).Known use of opioid or Cannabis-based treatments within 30 days before screening visit (visit 1 ).Patients for whom Cannabis or opioid therapy is not indicated, e.g., due to a history of non-response to opioid therapy or Cannabis-based medicines in the treatment of chronic non-specific low back pain in the past.Start of or planned non-drug pain therapy during run-in phase (physical or behavioral therapy).Start or planned start of an additional analgesic treatment during run-in phase.Ongoing monoamine oxidase inhibitor therapy at screening visit (visit 1 ).Patients with history of cancer in the last 5 years prior to screening visit (visit 1 ). Except for cutaneous basal cell or squamous cell cancer resolved by excision without recurrence and cervical cancer in situ resolved by excision with negative pap test.Painful comorbidities which could interfere with the low back pain intensity assessment during the study.Known history of human immunodeficiency virus (HIV) infectionSevere forms anemia, hematological I autoimmune I endocrine I renal I hepatic I respiratory I cardiovascular I neurological I gastrointestinal I symptomatic peripheral vascular diseases.Cardiovascular event in the last three months before screening visit (visit 1 ).Known uncontrolled hypertension (average systolic blood pressure >140 mmHg or average diastolic blood pressure >90 mmHg) and / or untreated hypothyroidism.Patients with Crigler-Najjar syndrome, Rotor syndrome and / or porphyria.History of major trauma or back surgery in the last 2 months prior to screening visit (visit 1 ).Known history of or current severe psychiatric illness.Known history of or current severe depression (not due to chronic low back pain) (assessed by Patient Health Questionnaire - 9) and / or suicidal ideation (assessed by Columbia-Suicide Severity Rating Scale) at screening visit (visit 1 ).Patients with severe respiratory depression.Patients with lung disease associated with impaired lung function (e.g., acute or severe bronchial asthma or hypercapnia / respiratory failure).Patients with conditions of increased intracranial pressure due to head injury or disease of the brain.Patients with existing or suspected paralytic ileus.Patients with intestinal obstruction due to intestinal paralysis.4.2 Objectives and endpoints4.2.7 ObjectivesThe primary objective of the study is to prove a reduced risk of developing constipation under treatment with the pharmaceutical formulation of the invention (the IMP) compared to an opioid therapy at the end of treatment phase.The secondary objectives are to further evaluate the safety and tolerability of the IMP compared to an opioid therapy and to compare efficacy of the pharmaceutical formulation of the invention (the IMP) to an opioid therapy.4.2.2 EndpointsThe primary endpoint is the number and proportion of constipation responders at the end of treatment phase. A constipation responder is defined as a patient with:1 . a change from baseline in Bowel Function Index (BFI) total score of at least 15 points at the end of treatment phase and2. a BFI total score of more than 28.8 at the end of treatment phase.Secondary endpoints of the study include:1. Number and percentage of 30% and 50% pain responders at the end of treatment phase2. Number and percentage of patients with a 30% and 50% improvement of the mean daily low back pain interference with sleep score at the end of treatment phase3. Total and relative days of intake of laxatives.4. Evaluation of withdrawal symptoms by Study Medication Withdrawal Questionnaire (SMWQ) scores5. Change from baseline in the mean daily low back pain intensity score6. Change from baseline in the mean daily low back pain interference with sleep score.7. Change from baseline in the Euro Quality of Life Health State Profile (EQ-5D-5L) dimensions and overall health index value7. Changes from baseline in Short Form 128. Change from baseline in the Roland Morris Disability (RMD) Questionnaire total score9. Percentage of patients by category of the patient’s global impression of change (PGIC)4.2.3 ResultsFirst results from the ongoing study show that patients have a reduced risk of developing constipation under treatment with the pharmaceutical formulation of the invention (the IMP) compared to an opioid therapy.380 patients have been randomized, 189 in the opioid arm and 191 in the receiving the pharmaceutical formulation of the invention (the IMP). 185 of these patients have already completed the treatment phase. At the end of the treatment period (visit 9). 13.0% of the patients in the opioid arm fulfilled the criteria for constipation (change from baseline in BFI total score of at least 15 points and a BFI total score of more than 28.8) compared to only 1.0% in the arm receiving the pharmaceutical formulation of the invention (the IMP).Table 15: Percentage of patients developing constipation taking the pharmaceutical formulation of the invention (the IMP) compared with an opioid therapy:In addition, a higher number of patients achieved a significant pain reduction of at least 30%. The number of responders increased over the course of the study with 66% for the IMP compared to 56% for patients treated with opioids at the end of the treatment phase (study week 27).Table 16: 30% pain response rates of patients taking the pharmaceutical formulation of the invention (the IMP) compared with response rate data for an opioid therapy:Overall, the invention (the IMP) showed an improved gastrointestinal tolerability (lower risk to develop constipation) as well as a superior pain reduction compared to opioids.

Claims

CLAIMS1. A composition for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene and at least one additional terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol.

2. The composition for use of claim 1 , wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in a ratio of between about 100:1 and 450:1 in the composition.

3. The composition for use of claim 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in a ratio of between about 50:1 and 250:1 in the composition.

4. The composition for use of any one of claims 1 to 3, wherein delta-9- tetrahydrocannabinol (THC) and beta-caryophyllene are present in a ratio of between about 50:1 and 250:1 in the composition.

5. The composition for use of any one of claims 1 to 4, wherein(a) delta-9-tetrahydrocannabinol (THC) and linalool are present in a ratio of between about 450:1 and 1400:1 in the composition;(b) THC and alpha-humulene are present in a ratio of between about 300: 1 and 725:1 in the composition;(c) THC and nerolidol are present in a ratio of between about 200:1 and 600:1 in the composition,(d) THC and caryophyllene oxide are present in a ratio of between about 1000:1 and 2150:1 in the composition;(e) THC and alpha-pinene are present in a ratio of between about 5850:1 and 16000:1 in the composition;(f) THC and camphene are present in a ratio of between about 7300:1 and 132950:1 in the composition;(g) THC and beta-pinene are present in a ratio of between about 6475:1 and 23100:1 in the composition;(h) THC and beta-myrcene are present in a ratio of between about 1950:1 and 6300:1 in the composition;(i) THC and limonene are present in a ratio of between about 1650: 1 and 5050: 1 in the composition;(j) THC and eucalyptol are present in a ratio of between about 5050:1 and 38650:1 in the composition;(k) THC and ocimene are present in a ratio of between about 2500:1 and 44700:1 in the composition;(l) THC and gamma-terpinene are present in a ratio of between about 4700:1 and 35750:1 in the composition;(m) THC and terpinolene are present in a ratio of between about 5450:1 and 129850:1 in the composition,(n) THC and alpha-terpinene are present in a ratio of between about 5150:1 and 58550:1 in the composition;(o) THC and para-cymene are present in a ratio of between about 4700:1 and 56700:1 in the composition;(p) THC isopulegol are present in a ratio of between about 4000:1 and 8000:1 in the composition; and / or(q) THC and geraniol are present in a ratio of between about 1300:1 and 18250:1 in the composition.

6. The composition for use of any one of claims 1 to 5, wherein the composition comprises delta-9-tetrahydrocannabinol (THC) in an amount of between about 2.5 and 10 percent by weight of the composition.

7. The composition for use of any one of claims 1 to 6, wherein the composition comprises alpha-bisabolol in an amount of between about 0.008 and 0.065 percent by weight of the composition.

8. The composition for use of any one of claims 1 to 7, wherein the composition comprises guaiol in an amount of between about 0.012 and 0.092 percent by weight of the composition.

9. The composition for use of any one of claims 1 to 8, wherein the composition comprises beta-caryophyllene in an amount of between about 0.012 and 0.094 percent by weight of the composition.

10. The composition for use of any one of claims 1 to 9, wherein the composition comprises(a) linalool in an amount of between about 0.001 and 0.014 percent by weight of the composition;(b) alpha-humulene in an amount of between about 0.003 and 0.028 percent by weight of the composition;(c) nerolidol in an amount of between about 0.004 and 0.035 percent by weight of the composition;(d) caryophyllene oxide in an amount of between about 0.001 and 0.0092 percent by weight of the composition; and / or(e) limonene in an amount of between about 0.0005 and 0.004 percent by weight of the composition.11 . The composition for use of any one of claims 1 to 10, wherein the composition is a Cannabis plant extract.

12. The composition for use of claim 11 , wherein the Cannabis plant extract is obtainable by solvent extraction of a Cannabis plant.

13. The composition for use of claim 11 or 12, wherein the Cannabis plant extract is obtainable by solvent extraction of flower material of the Cannabis plant.

14. The composition for use of any one of claims 11 to 13, wherein the Cannabis plant extract is an alcoholic extract.

15. The composition for use of any one of claims 1 to 14, wherein the composition is in liquid form.

16. The composition for use of any one of claims 1 to 15, wherein the composition comprises a carrier oil.

17. A pharmaceutical formulation for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising the composition of any one of claims 1 to 16.

18. The pharmaceutical formulation for use of claim 17, wherein the formulation comprises delta-9-tetrahydrocannabinol (THC) in an amount of between about 1 .0 and 2.5 percent and wherein THC and alpha-bisabolol are present in a ratio of between about 100:1 and 450:1 in the formulation, THC and guaiol are present in a ratio of between about 50:1 and 250:1 in the formulation and / or THC and betacaryophyllene are present in a ratio of between about 50:1 and 250:1 in the formulation.

19. The pharmaceutical formulation for use of claim 18, wherein delta-9- tetrahydrocannabinol (THC) and linalool are present in a ratio of between about 500:1 and 1330:1 in the formulation, THC and alpha-humulene are present in a ratio of between about 355:1 and 665:1 in the formulation, and THC and nerolidol are present in a ratio of between about 270:1 and 535:1 in the formulation.

20. The pharmaceutical formulation for use of any one of claims 17 to 19, wherein the formulation further comprises a carrier oil.

21. A method for treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain(CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles, the method comprising administering to a subject in need thereof an effective amount of the composition of any one of claims 1 to 16, or of the pharmaceutical formulation of claims 17 to 20.

22. The composition for use of claims 1 to 16, the pharmaceutical formulation for use of claims 17 to 20, or the method of claim 21 , wherein the composition or the pharmaceutical formulation is administered via oral-, oromucosal-, intra-nasal-, topical-, rectal- or vaginal administration.

23. A kit for use in the treatment and / or prevention of chronic musculoskeletal pain, including chronic low back pain (CLBP), chronic non-specific low back pain (CNSLBP), osteoarthritis and / or other chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles comprising component A and component B, wherein component A is the composition for use according to any one of claims 1 to and component B is a carrier oil.

24. The composition for use, the pharmaceutical formulation for use, the kit for use or the method of treatment of any one of the previous claims, wherein the chronic musculoskeletal pain conditions that affect (a) body area(s) or system(s) such as joints, tendons, ligaments, bones and / or muscles is selected from the group comprising back and neck pain, fibromyalgia, rheumatoid arthritis, psoriatic arthritis, gout, spondylarthritis, osteoporosis, osteopenia and sarcopenia.

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