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    Clinical Trial Results:
    The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial

    Summary
    EudraCT number
    		 2018-002315-98
    Trial protocol
    		 DK  
    Global end of trial date
    01 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2023
    First version publication date
    13 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MedicalcannabisMSSCI2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus Universitetshospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 165, Aarhus N, Denmark, 8220
    Public contact
    Neurologi, Aarhus Universitetshospital, 45 7845 4222, krissven@rm.dk
    Scientific contact
    Neurologi, Aarhus Universitetshospital, 45 7845 4222, krissven@rm.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on central neuropathic pain and spasticity in patients with multiple sclerosis and in patients with spinal cord injury
    Protection of trial subjects
    The study was conducted according to the Helsinki Declaration Guidelines and approved by the Danish Medicine Agency (2018071161), the Science Ethics Committee (VEK1-10-72-291-18), the Data Protection Agency (via the Central Denmark Region’s internal notification 1-16-02-582-18), and it was registered with the EU Clinical Trials Register EudraCT (2018-002315-98). The study was an investigator-initiated trial that followed the Good Clinical Practice (GCP) guidelines and was monitored by GCP units from Aarhus, Odense, and Copenhagen Universities, Denmark
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 134
    Worldwide total number of subjects
    134
    EEA total number of subjects
    134
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    116
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with Multiple Sclerosis (MS) and Spinal Cord Injury (SCI) were included between February 2019 and December 2021 at 10 MS clinics and 2 SCI clinics in Denmark

    Pre-assignment
    Screening details
    		 489 patients were screened for eligibility, 355 (72.6%) did not meet the inclusion/exclusion criteria (n=173, mostly due to ongoing use of cannabinoid/cannabis/CBM/opioids), or declined to participate (n=202, mainly due to the driving ban (n=88). Screening failure in 7 patients), In total, 134 patients (27.4% of all screened) were randomised

    Pre-assignment period milestones
    Number of subjects started
    		 134
    Number of subjects completed
    		 134

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients were randomized to treatment with either THC, CBD, THC&CBD, or placebo in a 1:1:1:1 ratio. Glostrup Pharmacy performed the computer-generated randomization list. Block randomization (block sizes 10-15) was used at the three largest sites (Aarhus, Viborg, and Copenhagen). The treatment allocation list was revealed on 1 March 2022 (after the last patient’s last visit and closure of the database). The AEs were evaluated before treatment allocation was revealed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 capsules of hard gelatin, white size 1 with hard fat and no active components Produced at Glostrup Pharmacy , Denmark
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The maximum daily dose was nine capsules.The daily dose was titrated for three weeks using a standard escalation schedule. If patients experienced an effect at a lower dose or AEs when escalating, individual lower doses were accepted (min. one capsule/day).

    Arm title
    		 delta-9-THC
    Arm description
    		 Capsules of hard gelatin (white size 1 ) with Dronabinol (natural THC) 2.5 mg Produced at Glostrup Pharmacy , Denmark
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dronabinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The maximum daily dose was nine capsules (divided into three daily doses, THC max dose=22.5 mg) The daily dose was titrated for three weeks using a standard escalation schedule. If patients experienced an effect at a lower dose or AEs when escalating, individual lower doses were accepted

    Arm title
    		 Cannabidiol (CBD)
    Arm description
    		 Capsules of hard gelatin, white size 1 with Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy , Denmark
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The maximum daily dose was nine capsules (divided into three daily doses, CBD max dose=45 mg). The daily dose was titrated for three weeks using a standard escalation schedule. If patients experienced an effect at a lower dose or AEs when escalating, individual lower doses were accepted (min. one capsule/day).

    Arm title
    		 THC/CBD
    Arm description
    		 Capsules of hard gelatin, white size 1 with Dronabinol (natural THC) 2.5 mg AND Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy Denmark
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dronabinol AND Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The maximum daily dose was nine capsules (divided into three daily doses, THC max dose=22.5 mg, CBD max dose=45 mg). The daily dose was titrated for three weeks using a standard escalation schedule. If patients experienced an effect at a lower dose or AEs when escalating, individual lower doses were accepted (min. one capsule/day).

    Number of subjects in period 1
    		Placebo delta-9-THC Cannabidiol (CBD) THC/CBD
    Started
    40
    32
    31
    31
    Completed
    37
    25
    30
    26
    Not completed
    3
    7
    1
    5
         wish to withdraw from treatment
    1
    -
    -
    -
         Physician decision
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    5
    -
    3
         Lack of efficacy
    1
    1
    -
    -
         Protocol deviation
    -
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 capsules of hard gelatin, white size 1 with hard fat and no active components Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    delta-9-THC
    Reporting group description
    		 Capsules of hard gelatin (white size 1 ) with Dronabinol (natural THC) 2.5 mg Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    Cannabidiol (CBD)
    Reporting group description
    		 Capsules of hard gelatin, white size 1 with Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    THC/CBD
    Reporting group description
    		 Capsules of hard gelatin, white size 1 with Dronabinol (natural THC) 2.5 mg AND Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy Denmark

    Reporting group values
    		 Placebo delta-9-THC Cannabidiol (CBD) THC/CBD Total
    Number of subjects
    		 40 32 31 31 134
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 52.2 ( 10.4 ) 54.1 ( 10.4 ) 53 ( 9.8 ) 51.1 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 21 22 28 99
        Male
    		 12 11 9 3 35
    Patient group
    Units: Subjects
        MS
    		 34 29 26 30 119
        SCI
    		 6 3 5 1 15
    Subject analysis sets

    Subject analysis set title
    placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to placebo

    Subject analysis set title
    THC
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to THC

    Subject analysis set title
    CBD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to CBD

    Subject analysis set title
    THC/CBD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to THC/CBD

    Subject analysis sets values
    		 placebo THC CBD THC/CBD
    Number of subjects
    40
    32
    31
    31
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        geometric mean (standard deviation)
    52.2 ( 10.4 )
    54.1 ( 10.4 )
    53.0 ( 9.8 )
    51.1 ( 12.7 )
    Gender categorical
    Units: Subjects
        Female
    28
    21
    22
    28
        Male
    12
    11
    9
    3
    Patient group
    Units: Subjects
        MS
    34
    29
    26
    30
        SCI
    6
    3
    5
    1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 capsules of hard gelatin, white size 1 with hard fat and no active components Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    delta-9-THC
    Reporting group description
    		 Capsules of hard gelatin (white size 1 ) with Dronabinol (natural THC) 2.5 mg Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    Cannabidiol (CBD)
    Reporting group description
    		 Capsules of hard gelatin, white size 1 with Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy , Denmark

    Reporting group title
    THC/CBD
    Reporting group description
    		 Capsules of hard gelatin, white size 1 with Dronabinol (natural THC) 2.5 mg AND Cannabidiol (synthetic CBD) 5 mg Produced at Glostrup Pharmacy Denmark

    Subject analysis set title
    placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to placebo

    Subject analysis set title
    THC
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to THC

    Subject analysis set title
    CBD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to CBD

    Subject analysis set title
    THC/CBD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to THC/CBD

    Primary: NRS pain

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    End point title
    		 NRS pain
    End point description
    Difference in mean pain intensity from baseline Intention to treat: At least one dose of study medication
    End point type
    Primary
    End point timeframe
    6 weeks of treatment
    End point values
    		 Placebo delta-9-THC Cannabidiol (CBD) THC/CBD
    Number of subjects analysed
    35
    24
    27
    28
    Units: 0-10
        geometric mean (standard deviation)
    -1.8 ( 1.8 )
    -1.4 ( 2 )
    -1.4 ( 1.6 )
    -1.6 ( 1.8 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Comparison of mean difference in NRS-pain between treatment arms.
    Comparison groups
    Placebo v delta-9-THC v Cannabidiol (CBD) v THC/CBD
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.74
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - ANOVA one-way

    Primary: NRS spasticity

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    End point title
    		 NRS spasticity
    End point description
    Difference in mean spasticity intensity from baseline Intention to treat: At least one dose of study medication
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Placebo delta-9-THC Cannabidiol (CBD) THC/CBD
    Number of subjects analysed
    29
    25
    26
    20
    Units: 0-10
        geometric mean (standard deviation)
    -1.7 ( 2.3 )
    -1.5 ( 2.0 )
    -1.3 ( 1.9 )
    -1.6 ( 2.4 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Comparison of mean difference NRS.spasticity between treatment arms
    Comparison groups
    Placebo v delta-9-THC v Cannabidiol (CBD) v THC/CBD
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.89
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - ANOVA one-way

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    11 weeks (treatment and follow-up)
    Adverse event reporting additional description
    All AEs (weekly in e-diary and at visits/phone consultation) were collected. All AE questionnaires were evaluated by the sponsor site and allocated to “previous reported and unrelated”, “unrelated”, “possible or certainly related”, and “cannot be assessed”. An AE was included in the inventory if it was rated “possible” or “certainly related”.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    delta-9-THC
    Reporting group description
    		 -

    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    THC/CBD
    Reporting group description
    		 -

    Serious adverse events
    		 delta-9-THC Cannabidiol Placebo THC/CBD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 31 (3.23%)
    2 / 40 (5.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 40 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallstone
    Additional description: gallstone attack in a patient with known gallstone and history of gallstone attacks
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 40 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 40 (2.50%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 40 (2.50%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 40 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fever
    Additional description: unspecific
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 40 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 delta-9-THC Cannabidiol Placebo THC/CBD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 32 (78.13%)
    19 / 31 (61.29%)
    25 / 40 (62.50%)
    28 / 31 (90.32%)
    Investigations
    others
         subjects affected / exposed
    7 / 32 (21.88%)
    3 / 31 (9.68%)
    3 / 40 (7.50%)
    14 / 31 (45.16%)
         occurrences all number
    7
    3
    3
    14
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    6 / 32 (18.75%)
    2 / 31 (6.45%)
    0 / 40 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    6
    2
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 32 (46.88%)
    10 / 31 (32.26%)
    13 / 40 (32.50%)
    13 / 31 (41.94%)
         occurrences all number
    15
    10
    13
    13
    Dizziness
         subjects affected / exposed
    19 / 32 (59.38%)
    5 / 31 (16.13%)
    12 / 40 (30.00%)
    18 / 31 (58.06%)
         occurrences all number
    19
    5
    12
    18
    Tiredness/sleepiness
         subjects affected / exposed
    17 / 32 (53.13%)
    14 / 31 (45.16%)
    14 / 40 (35.00%)
    17 / 31 (54.84%)
         occurrences all number
    17
    14
    14
    17
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    6 / 32 (18.75%)
    4 / 31 (12.90%)
    4 / 40 (10.00%)
    4 / 31 (12.90%)
         occurrences all number
    6
    4
    4
    4
    Eye disorders
    Visual disturbances
         subjects affected / exposed
    5 / 32 (15.63%)
    2 / 31 (6.45%)
    3 / 40 (7.50%)
    3 / 31 (9.68%)
         occurrences all number
    5
    2
    3
    3
    Gastrointestinal disorders
    mouth dryness
         subjects affected / exposed
    17 / 32 (53.13%)
    9 / 31 (29.03%)
    11 / 40 (27.50%)
    21 / 31 (67.74%)
         occurrences all number
    17
    9
    11
    21
    Stomach ache
         subjects affected / exposed
    8 / 32 (25.00%)
    6 / 31 (19.35%)
    3 / 40 (7.50%)
    6 / 31 (19.35%)
         occurrences all number
    8
    6
    3
    6
    Nausea
         subjects affected / exposed
    6 / 32 (18.75%)
    5 / 31 (16.13%)
    4 / 40 (10.00%)
    11 / 31 (35.48%)
         occurrences all number
    6
    5
    4
    11
    Diarrhoea
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    2 / 40 (5.00%)
    7 / 31 (22.58%)
         occurrences all number
    3
    0
    2
    7
    Skin and subcutaneous tissue disorders
    Flushing
         subjects affected / exposed
    6 / 32 (18.75%)
    1 / 31 (3.23%)
    3 / 40 (7.50%)
    2 / 31 (6.45%)
         occurrences all number
    6
    1
    3
    2
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 31 (12.90%)
    4 / 40 (10.00%)
    2 / 31 (6.45%)
         occurrences all number
    2
    4
    4
    2
    Nightmare
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    1 / 40 (2.50%)
    2 / 31 (6.45%)
         occurrences all number
    1
    0
    1
    2
    Euphoric mood
         subjects affected / exposed
    5 / 32 (15.63%)
    1 / 31 (3.23%)
    1 / 40 (2.50%)
    4 / 31 (12.90%)
         occurrences all number
    5
    1
    1
    4
    Anxiety
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 31 (6.45%)
    1 / 40 (2.50%)
    3 / 31 (9.68%)
         occurrences all number
    3
    2
    1
    3
    Nervousness
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 31 (9.68%)
    3 / 40 (7.50%)
    5 / 31 (16.13%)
         occurrences all number
    2
    3
    3
    5
    Hallucination
         subjects affected / exposed
    3 / 32 (9.38%)
    3 / 31 (9.68%)
    1 / 40 (2.50%)
    0 / 31 (0.00%)
         occurrences all number
    3
    3
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle pain
         subjects affected / exposed
    6 / 32 (18.75%)
    4 / 31 (12.90%)
    10 / 40 (25.00%)
    6 / 31 (19.35%)
         occurrences all number
    6
    4
    10
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Nov 2019
    due to additional documentation (GMP)from the laboratory that controlled the study medicine (please note that the documentation was not related to the study medicine)
    26 Feb 2020
    11 Mar 2020
    COVID-19 lockdown
    28 Apr 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    we did not reach the planned number of patients, due to the interruptions and the reluctance of patients to participate due to the driving ban during the study, ongoing use of opioids or cannabis/CBM, and other reasons.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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