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The following sections provide relevant information about the Medicinal Cannabis Scheme for doctors, pharmacists and other health professionals involved in the provision of quality medicinal cannabis products for therapeutic use by patients. Cannabidiol prescription in clinical practice: an audit on the first 400 patients in New Zealand Cannabidiol (CBD) is the non-euphoriant component of cannabis. In 2017, the New Zealand Misuse of

Medicinal Cannabis Agency – Information for health professionals

The following sections provide relevant information about the Medicinal Cannabis Scheme for doctors, pharmacists and other health professionals involved in the provision of quality medicinal cannabis products for therapeutic use by patients.

What is a medicinal cannabis product?

A medicinal cannabis product is a prescription medicine which is either dried cannabis or a pharmaceutical dosage form containing one or more ingredients extracted from the Cannabis plant. All medicinal cannabis products are subject to the requirements of the Medicinal Cannabis Scheme and must meet the minimum quality standard. Except for Sativex™, all medicinal cannabis products are unapproved medicines. There are two broad categories of medicinal cannabis products which are detailed below.

CBD products

All cannabidiol (CBD) products are prescription medicines. A CBD product may contain only trace amounts of tetrahydrocannabinol (THC) and certain other related substances and cannot contain any other controlled drugs or psychoactive substances. See a detailed definition of a CBD product.

Controlled drugs

Any medicinal cannabis product which is not a CBD product is a Class B1 controlled drug. These may contain any level of cannabinoids and include all dried flower products.

Across both categories, medicinal cannabis products do not include:

  • medicines which contain ingredients that are not derived from the Cannabis plant
  • sterile dosage forms such as eye drops
  • any product intended for smoking
  • any product meeting the definition of a ‘food’ under the Food Act 2014.

Medicinal cannabis minimum quality standard

All medicinal cannabis products distributed in New Zealand must meet the medicinal cannabis minimum quality standards (MQS). The MQS have been designed to provide doctors with confidence in the quality and consistency of any medicinal cannabis products they prescribe to their patients. The standards do not include an assessment of the safety or efficacy of the product.

Prescribing medicinal cannabis

A medicinal cannabis product must be prescribed by a doctor registered to practice in New Zealand. Any medicinal cannabis product that has either been verified against the MQS or approved as a medicine can be prescribed without specialist recommendation or Ministerial approval.

Medicinal cannabis products that meet the MQS, or are approved medicines are listed here.

Prescriptions must meet the legal requirements and must specify:

  • the product brand and composition of active ingredients (eg, tetrahydrocannabinol and cannabidiol)
  • directions for use, including the prescribed dose and route of administration, including where appropriate, the device by which the product is to be administered.

No medicinal cannabis products are approved as medicines. It is recommended to prescribe by brand to ensure your patient receives the same medicine at each point of dispensing, and in line with the requirements for prescribing an unapproved medicine.

  • prescriptions for CBD products must be for no more than a three-month supply
  • prescriptions for controlled drug products (including Sativex™) must be either handwritten on a controlled drug prescription form or be on a personally signed barcoded prescription issued from the NZePS system, for no more than one month’s supply.

Unverified medicinal cannabis products

Quality-verified products or approved medicines should be trialled before unverified products are prescribed. Unverified products have no assurance of quality or of the specified active cannabinoid content on the product label.

A doctor may not prescribe a medicinal cannabis product that has not been verified as meeting the minimum quality standard unless approval for a named patient has been granted by the Minister of Health following an application from a relevant medical specialist or the Chief Medical Officer of a District Health Board.

Please contact the Medicinal Cannabis Agency for more information ( [email protected] ).

Medical practitioners should ensure they are familiar with the requirements of the Medicines Act 1981 and the Medsafe guidance on the Use of Unapproved Medicines and Unapproved Use of Medicines.

Dispensing medicinal cannabis

Medicinal cannabis products must be dispensed in the same manner as other prescription medicines and controlled drugs.

Prescriptions for medicinal cannabis products:

  • must satisfy all legal requirements
  • must include an approval number showing Ministerial approval has been granted to prescribe a controlled drug product if the product is not listed here
  • must be for no more than three-months supply in the case of a CBD product
  • must be for no more than one-month supply in the case of a controlled drug product.

Brand substitution cannot take place without the prescriber’s explicit authorisation. As all medicinal cannabis products (except Sativex™) are unapproved medicines, the prescriber has to be satisfied that the brand of medicine prescribed is appropriate for their patient (including having informed consent). Without verification against the MQS or medicines approval, there is no assurance that any two brands contain the same active ingredient(s).

Importing unverified medicinal cannabis products

Unverified products may only be imported into New Zealand by a registered doctor, or pharmacist pursuant to a prescription, in an amount required for a named patient.

A licence to import a controlled drug is required for each consignment where the unverified medicinal cannabis product is not a CBD product. Expectations of future prescriptions is not a reasonable excuse to import unverified medicinal cannabis products.

Vaporisers

The administration of some medicinal cannabis products requires a vaporiser. Vaporisers can be purchased from the NZ supplier, or imported directly. The Misuse of Drugs (Prohibition of Utensils) Notice 2020 sets out that a vaporiser can be imported and sold, only if it has been approved as a medical device by an overseas regulator. This ensures the vaporiser will provide a safe method for administering medicinal cannabis. Other vaporiser devices, and utensils with prohibited features, continue to be prohibited from importation into New Zealand.

Medical devices, including vaporisers, must be notified to WAND by the importer, manufacturer or supplier. Please see the Medsafe guidance for more information.

If you are uncertain whether a specific vaporiser has been approved as a medical device, please contact [email protected] .

Where to find more information

An overview on medicinal cannabis for health practitioners is available on the Best Practice Advocacy Centre (BPAC) website. The Ministry and BPAC have collaborated to produce a primer resource on medicinal cannabis for healthcare professionals

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Clinical guidance has been produced by the Therapeutic Goods Administration (TGA) in Australia and Health Canada. While not specific to any product, this information may be useful for those wanting to prescribe medicinal cannabis to their patients:

Cannabidiol prescription in clinical practice: an audit on the first 400 patients in New Zealand

Cannabidiol (CBD) is the non-euphoriant component of cannabis. In 2017, the New Zealand Misuse of Drugs Regulations (1977) were amended, allowing doctors to prescribe CBD. Therapeutic benefit and tolerability of CBD remains unclear.

To review the changes in self-reported quality of life measurements, drug tolerability, and dose-dependent relationships in patients prescribed CBD oil for various conditions at a single institution.

Design & setting

An audit including all patients (n = 400) presenting to Cannabis Care, New Zealand, between 7 December 2017 and 7 December 2018 seeking CBD prescriptions

Method

Indications for CBD use were recorded at baseline. Outcomes included EuroQol quality of life measures at baseline and after 3 weeks of use, patient-reported satisfaction, incidence of side effects, and patient-titrated dosage levels of CBD.

Results

Conclusion

There may be analgesic and anxiolytic benefits of CBD in patients with non-cancer chronic pain and mental health conditions such as anxiety. CBD is well tolerated, making it safe to trial for non-cancer chronic pain, mental health, neurological, and cancer symptoms.

How this fits in

CBD prescription in primary care was legalised in New Zealand in 2017. Previous preclinical trials have shown CBD to have anxiolytic and anti-inflammatory properties but there remains a paucity of studies investigating its therapeutic potential. In this quantitative observational study of the first 400 patients prescribed CBD in New Zealand, CBD was well tolerated amongst patients with a wide range of conditions and symptoms. Quality-of-life benefit was experienced to a greater degree in patients living with non-cancer chronic pain and anxiety-related mental-health conditions, and to a lesser degree in patients with cancer or neurological symptoms.

Introduction

With the amendment of the New Zealand Misuse of Drugs Regulations 1977 in 2017, CBD has become a legal prescription medicine. The amendment recognises the right of New Zealand doctors to prescribe CBD products that contain no more of 2% of 9-Δ-tetrahydrocannabinol (9-Δ-THC) in the product. 1

CBD and 9-Δ-THC are cannabinoids, active compounds found within the Cannabis genus of plants. 2 While 9-Δ-THC is the main psychoactive component responsible for euphoria and the ‘high’ associated with marijuana, CBD is the non-euphoriant component. 2 , 3

CBD is currently FDA-approved for the treatment of Dravet and Lennox-Gastaut syndrome, two childhood seizure disorders. 4 Randomised controlled trials (RCTs) have shown that, when CBD is added to existing anti-epileptic medication in patients with these syndromes, seizure frequency decreases. 5 , 6

However, CBD shows potential therapeutic use beyond this. Pre-clinical studies demonstrate that CBD has potential anti-inflammatory effects via inhibition of immune cell migration, which may be useful in chronic inflammatory conditions. 7

Moreover, preclinical studies have demonstrated anxiolytic effects of CBD. 3 , 8 – 10 Crippa et al found that in patients with generalised anxiety disorder given 400 mg of oral CBD, there was decreased cerebral blood flow to anxiety processing areas of the brain and a decrease in patient-reported anxiety when compared to placebo. 8 CBD in one double-blinded placebo-controlled RCT decreased symptoms of social anxiety disorder patients and fear of public speaking. 10 CBD may also reduce psychotic symptoms of schizophrenia. 11

CBD appears to be safe for patients, with a recent phase I dosage trial showing purified CBD oil is well tolerated up to doses of 6000 mg. 12 However, due to a paucity of clinical studies, prescribing guidelines are lacking.

The aim of this study was to conduct a clinical audit on the patient population referred to Cannabis Care (a primary care clinic in Auckland, New Zealand) for CBD oil. The authors explored the indications for prescribing CBD oil, patient quality of life, patient satisfaction, and self-titrated dosage levels.

Method

The STROBE statement for reporting observational studies was followed. 13

Patients

Patients included in this audit were those who were prescribed CBD from 7 December 2017 to 7 December 2018. Patients included in this audit either were referred by their primary care provider or self-referred to the service. Patients were prescribed CBD oil (Tilray CBD100, Tilray, Nanaimo, BC, Canada) containing 100 mg CBD/mL in 25 mL bottles administered orally via a dropper. Bottles costed approximately USD300 each, which was self-funded as CBD is not on the New Zealand government-subsidised pharmaceutical schedule (PHARMAC).

Outcomes

Patient sex, age, and details of medical condition were recorded at first consultation. Each participant was grouped into one of four broad clinical groups based on their presenting medical symptoms: non-cancer chronic pain symptoms, neurological symptoms, mental health-related symptoms, or cancer symptoms. When a patient presented with symptoms fitting multiple categories, the clinician assigned the patient to the category fitting their primary presenting complaint.

Patients completed an EQ-5D-5L questionnaire at baseline before taking CBD, and again after at least 3 weeks of using the medicine as part of routine clinical assessment. The EQ-5D-5L is a two-part tool consisting of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ-VAS). 14 The descriptive system measures five domains (mobility, self-care, usual activities, pain or discomfort, anxiety or depression) each with five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ-VAS is a 20 cm vertical printed scale from 0 to 100 whereby the upper endpoint of the scale corresponds the ‘best health you can imagine’ and the lower corresponds to the ‘worst health you can imagine’. The patient rated their current overall health on this visual scale to yield a corresponding numerical score.

Patients also rated their satisfaction with their CBD use at follow-up. They rated their experience as ‘no benefit, good, very good, or excellent’ and reported any side effects. In addition, variations in patient dosage and the duration and frequency of CBD oil intake were recorded where possible.

Statistical methods

The EQ-5D-5L data was measured on ordinal scales and hence considered as non-parametric data. The EQ-VAS scores were recorded on a continuous scale and treated as a parametric variable. Non-parametric data was presented as median (interquartile range [IQR]) and analysed for differences using the Wilcoxon rank sum test. Change in patient EQ-VAS scores was presented as mean (standard deviation [SD]) and analysed using one-way analysis of variance (ANOVA) to assess any differences between indication categories. Binary logistic regression was used to analyse potential dose-dependent responses, dose of CBD, and patient-reported benefit.

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Categorical data such as the indications for CBD, patient satisfaction with CBD use, and side effects of use were presented as frequencies. A P value of ≤0.05 was taken as statistically significant. SPSS software (version 23.0) was used for statistical analysis.

Results

A total of 400 patients presented to Cannabis Care from 7 December 2017 to 7 December 2018. Three patients did not receive a prescription based on a clinician decision that they would not benefit. Patients receiving CBD prescription consisted of 214 females (53.9%) and 183 males (46.1%), for a total of 397 individuals. The mean age of patients was 51.48 years (SD 19.1). Of those prescribed CBD, 61 patients (15.4%) fit more than one category of indication and were assigned to a group based on their primary condition.

Patient indication for CBD prescription is shown in Table 1 . The non-cancer pain symptoms group included patients with fibromyalgia, osteoarthritis, rheumatoid arthritis, neuropathic pain, chronic non-specific pain, pain due to ulcerative colitis, and migraines. Cancer-related symptoms included pain, nausea, poor appetite, emotional distress, and adverse effects of radiotherapy and/or chemotherapy treatment. Mental health symptoms included anxiety disorders, depressive disorders, post-traumatic stress disorder, and insomnia. Neurological symptoms included Parkinson’s disease, multiple sclerosis, epilepsy, autism spectrum disorder with challenging behaviour, amyotrophic lateral sclerosis, multiple system atrophy, various neuropathies, and tremors.

Table 1.

Characteristic Frequency, n Proportion, %
Mean age, years (±SD) 51.48 (±19.1)
Sex Male 183 46.1
Female 214 53.9
Indication for CBD prescription Non-cancer pain symptoms 181 45.6
Mental health symptoms 64 16.1
Neurological symptoms 60 15.1
Cancer symptoms 92 23.2

Of the 397 patients initially prescribed the CBD oil, 253 (63.7%) were followed up either through a second appointment with the clinician or by phone. In total, 250 patients (63.0%) reported their satisfaction with CBD use, with three patients (0.8%) refusing to comment. Within these 250 patients, a subset of 110 patients (27.7%) completed before and after EQ-5D-5L questionnaires; 144 patients (36.3%) did not complete follow-up assessment, with 82 patients (20.7%) lost to follow-up and 62 patients (15.6%) choosing not to take the CBD. Reasons for patients not taking the CBD included death, financial barriers preventing purchase of the oil, severe illness, participation in a clinical trial, or consumption of alternative illicit cannabis products.

Median follow up duration for patients who completed their CBD prescription was 36 days (IQR 28–65).

Outcomes of CBD treatment

Results from Wilcoxon rank sum tests for EQ-5D-5L domains found that patients experiencing non-cancer pain symptoms had a significant improvement of self-reported mobility scores (P = 0.02), ability to complete their usual activities (P = 0.007), self-reported pain (P<0.001), and self-reported anxiety or depression (P = 0.017). Patients with mental-health related symptoms experienced improvements to their ability to carry out their usual activities (P = 0.002), pain (P = 0.039), and anxiety or depression (P = 0.02). Patients with neurological symptoms experienced no statistically significant differences in any of the five domains. Patients with cancer symptoms experienced improvements in pain (P = 0.047). Complete results of EQ-5D-5L questionnaires are shown in Table 2 .

Table 2.

Indication for CBD prescription Domain of
EQ-5D-5L
Baseline EQ-5D-5L scores, median (IQR) Follow-up EQ-5D-5L scores, median (IQR) P value
Non-cancer pain symptoms (n = 53) Mobility 2.0 (1.0 to 3.0) 2.0 (1.0 to 3.0) 0.022
Self-care 1.0 (1.0 to 2.0) 1.0 (1.0 to 2.0) 0.046
Usual activities 3.0 (2.0 to 4.0) 2.0 (1.0 to 3.0) 0.007
Pain/discomfort 3.5 (3.0 to 4.0) 3.0 (2.0 to 3.0)
Anxiety/depression 2.0 (1.0 to 3.0) 2.0 (1.0 to 2.0) 0.017
Mental health symptoms (n = 21) Mobility 1.0 (1.0 to 1.0) 1.0 (1.0 to 1.0) 0.577
Self-care 1.0 (1.0 to 1.75) 1.0 (1.0 to 1.0) 0.096
Usual activities 3.0 (2.0 to 3.0) 1.0 (1.0 to 2.0) 0.002
Pain/discomfort 2.0 (1.0 to 3.0) 1.0 (1.0 to 2.0) 0.039
Anxiety/depression 4.0 (3.0 to 4.0) 2.0 (1.5 to 3.0) 0.002
Neurological symptoms (n = 11) Mobility 1.0 (1.0 to 3.0) 1.5 (1.0 to 2.0) 0.317
Self-care 1.0 (1.0 to 3.0) 1.5 (1.0 to 2.0) 0.317
Usual activities 3.0 (1.75 to 4.0) 2.5 (1.75 to 3.25) 0.194
Pain/discomfort 3.0 (1.5 to 3.5) 3.0 (1.5 to 3.0) 0.18
Anxiety/depression 3.0 (2.0 to 3.0) 1.5 (1.0 to 3.0) 0.194
Cancer symptoms (n = 24) Mobility 1.0 (1.0 to 2.0) 1.0 (1.0 to 2.0) 0.56
Self-care 1.0 (1.0 to 2.0) 1.0 (1.0 to 1.0) 1
Usual activities 2.0 (1.0 to 2.75) 2.0 (1.0 to 3.0) 1
Pain/discomfort 3.0 (2.0 to 3.0) 2.0 (1.0 to 2.5) 0.047
Anxiety/depression 2.0 (1.0 to 3.0) 1.0 (1.0 to 2.0) 0.11

Score of 1 = no problems, 2 = slight problems, 3= moderate problems, 4 = severe problems, 5 = extreme problems. P values are calculated from Wilcoxon rank sum tests. ‘Before’ scores taken at first consultation. ‘After’ scores taken after at least 3 weeks of cannabidiol intake.

CBD = cannabidiol. IQR = interquartile range.

Patient-reported satisfaction of CBD treatment found that 175 patients (70.0% of the 250 patients for whom there was available data, or 44.1% of the 397 patients prescribed the CBD), reported some level of satisfaction with CBD use (good, very good, or excellent). Seventy-five patients (30.0% of 250 patients, or 19.0% of 397 patients) reported no benefit from CBD use. There was no statistically significant relationship found between patient age or sex and patient-reported satisfaction.

Side effects

Adverse effects such as sedation and vivid dreams were experienced by 25 out of 253 patients (9.9%). A worsening of a pre-existing condition was reported by 2 of 253 (0.8%) patients upon follow-up. Thirty-eight of followed-up patients (15.0%) reported positive side effects of CBD use, such as improved sleep or improved appetite. Side effects experienced by follow-up patients are summarised in Table 3 .

Table 3.

Side effect Frequency, n (%)
Positive effects
Improved sleep 31 (12.3)
Improved appetite 7 (2.8)
Adverse effects
Sedation 5 (2.0)
Vivid dreams 5 (2.0)
Emotional disturbances eg, irritable, depressed, anxious 5 (2.0)
Disorientation 3 (1.2)
Sleeplessness 1 (0.4)
Nausea 1 (0.4)
Constipation 1 (0.4)
Diarrhoea 1 (0.4)
Headaches 1 (0.4)
Oral mucosa irritation 1 (0.4)
Hallucinations 1 (0.4)

Dosage

Amongst those who completed the course of CBD, the dose per day ranged from 40mg/day to 300mg/day. However, dosage information was incomplete, existing for only 110 patients out of the 253 followed-up patients (43.5%). The clinician recommended dosing to at least 100 mg/day. Overall dosage between patients varied widely and was reported inconsistently by patients. Binary logistic regression analysis was conducted for the existing values and there was no significant association between dosage and patient-reported benefit from CBD (P = 0.145).

Discussion

Summary

CBD treatment improved self-reported quality of life measures for patients in the non-cancer pain and mental health-related symptom groups. There was no statistically significant improvement in those with cancer or neurological symptoms. Of those prescribed CBD, 44.1% (or 70.0% of the follow-up group) reported good to excellent benefit for relatively intractable conditions; 19.0% of those prescribed CBD (or 30.0% of the follow-up group) reported no benefit. CBD is well tolerated in most patients and may be of benefit to patients with various intractable chronic conditions.

Strengths and limitations

The strength of this study is that it assesses effects of CBD on a large range of chronic medical conditions in a clinical context. Only three patients were excluded (due to extreme severity of their conditions).

There are several limitations to this present audit. There was a large loss to follow-up due to patients not attending follow-up and cost barriers. Hence, the results reported may not be fully representative of the entire patient population. Moreover, patients had to pay USD300 for 2500 mg of the CBD oil, USD150 for an initial consultation, and USD75 for follow-up. Most patients had refractory chronic pain and conditions resistant to conventional treatment uncommon in the wider population, increasing risk of selection bias. These patients are unlikely to be representative of a wider, more generalised cohort of patients. It is difficult to elucidate the effect of selection bias on these findings. The high cost barriers may augment the placebo effect of treatment, 15 resulting in an overestimation of treatment effects. However, due to many patients having resistant symptoms, CBD may conversely prove more efficacious in patients with less severe symptoms.

The follow-up period was variable, resulting in interviews with some patients who had stopped taking CBD for a period of months. This may have confounded the patient’s recollection of the effects of CBD, likely causing an underestimation of the effect. Some follow-up was completed by the clinician instead of a non-clinical author. This increased the risk of expectation bias by the clinician, likely overestimating the effect. Considering these limitations, results should be interpreted with the appropriate caution.

Comparison with existing literature

Numerous preclinical trials 9 , 10 and neuro-imaging studies 8 have demonstrated the anxiolytic effects of CBD. A recently published case-series in psychiatric patients found a benefit of CBD for anxiety and sleep, 16 which is in agreement with the above findings.

On a pharmacological level, preclinical trials suggest CBD’s analgesic action is due to its effect on certain receptors: TRPV1 and a3 GlyRs, involved in nociceptive transmission. However, human studies are still inconclusive. 17 – 19 The apparent benefit of CBD on pain reported by patients in this audit remains difficult to interpret. Current guidelines for the prescription of medicinal cannabis, including both 9-Δ-THC and CBD, recommend it as a third-line treatment for neuropathic pain, palliative and end-of-life pain, chemotherapy-induced nausea and vomiting, and spasticity due to multiple sclerosis or spinal cord injury . 20 However, RCTs investigating the use of CBD alone for the treatment of pain are lacking.

The ineffectiveness of the CBD oil for 75 of the 250 patients with available data (30.0%) may be due to lack of patient compliance and inadequate dosing. The expense of the pure CBD 100 mg/mL may have influenced patient attitudes towards this matter. Previous studies investigating CBD’s anxiolytic effect have shown a U-shaped dose curve with highest efficacy at 300 mg as a single-dose. 21 This audit did not find a statistically significant dose-response, likely due to missing data and the aforementioned factors regarding financial cost.

CBD’s ineffectiveness in improving self-reported health in patients in the cancer and neurological groups may be due to the high heterogeneity of the clinical presentations within these groups. Additionally, patients within these groups had more severe disease progression compared to the mental health and non-cancer pain symptom groups, which may have limited efficacy.

Overall, CBD treatment was well tolerated with mild adverse effects, most commonly related to sedation. This is consistent with the findings of a phase I clinical trial showing the main side effects of CBD were related to the gastrointestinal and central nervous system. 12 Patient-reported sleep benefits are likely related to these sedative effects. While cannabis (containing both 9-Δ-THC and CBD) has been indicated for use as an appetite stimulant in HIV-affected patients with cachexia, 22 , 23 it remains unclear if CBD alone has significant appetite stimulating effects beyond placebo. Long-term side effects were not analysed in this current audit and future study is still needed to clarify chronic effects of CBD administration. 24

Implications for research and practice

Some urgency on this topic exists due to the increasing worldwide legalisation of cannabis and its related products. A focus should be placed on confirming the anxiolytic effects of CBD in clinical conditions. Future studies should investigate the effectiveness of full spectrum CBD oil with the retention of terpenes, the essential oils found in cannabis plants. Terpenes may enhance the effects of pure CBD because of a synergistic effect known as the entourage effect.

Overall, this audit demonstrated the potential benefit of CBD in treating anxiety and pain. The present study shows that it improves quality of life for a diverse range of patients. CBD in this population has been shown to be safe and well tolerated. However, despite potential biases of patients influenced by the high treatment cost, pure CBD is not effective for all. Benefit was more pronounced in patients who had conditions with less severe disease progression (such as mental health or non-cancer chronic pain conditions). Due to lack of a control group, high drop-out rate, and an extreme patient population, these study results should be interpreted with caution. Future studies should investigate effects of long-term CBD use, which could not be analysed in this present audit.

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