Trial Outcomes & Findings for Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome (NCT NCT03848832)

NCT ID: NCT03848832

Last Updated: 2022-09-02

Results Overview

RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is "not true as far as you know," 1 indicating an item is "somewhat or sometimes true," and 2 indicating an item that is "very true or often true." Item 31 ("Uses eye gaze to convey feelings, needs and wishes") is reverse scored (0 indicating "very true or often true", 1 indicating "somewhat or sometimes true," and 2 indicating "not true as far as you know"). The total summed score ranges from 0 to 90, with higher scores representing greater severity.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline; Week 24
• Results posted on: 2022-09-02

Participant Flow

A total of 41 participants were screened for eligibility; 29 were randomized to the study treatments, and 12 were screen failures.

Participant milestones

Measure	5 mg/kg/Day GWP42003-P Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).	15 mg/kg/Day GWP42003-P Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Overall Study STARTED	10	9	10
Overall Study COMPLETED	7	6	4
Overall Study NOT COMPLETED	3	3	6

Reasons for withdrawal

Measure	5 mg/kg/Day GWP42003-P Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).	15 mg/kg/Day GWP42003-P Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Overall Study Withdrawal of Consent Due To Covid-19	0	0	1
Overall Study Withdrawal by Subject	0	0	1
Overall Study Withdrawal (Covid-19)	0	2	0
Overall Study Physician Decision	2	1	3
Overall Study Sponsor Decision - Covid-19 Precaution	0	0	1
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome

Baseline characteristics by cohort

Measure	5 mg/kg/Day GWP42003-P n=11 Participants Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).	15 mg/kg/Day GWP42003-P n=9 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	9.7 years STANDARD_DEVIATION 6.02 • n=5 Participants	10.7 years STANDARD_DEVIATION 3.64 • n=7 Participants	8.6 years STANDARD_DEVIATION 5.53 • n=5 Participants	9.7 years STANDARD_DEVIATION 5.11 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline; Week 24

Population: Intent-to-Treat (ITT) Set: All randomized participants who received at least 1 dose of drug in the trial, and had Baseline efficacy data. Participants with non-missing data were included for analysis.

RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is "not true as far as you know," 1 indicating an item is "somewhat or sometimes true," and 2 indicating an item that is "very true or often true." Item 31 ("Uses eye gaze to convey feelings, needs and wishes") is reverse scored (0 indicating "very true or often true", 1 indicating "somewhat or sometimes true," and 2 indicating "not true as far as you know"). The total summed score ranges from 0 to 90, with higher scores representing greater severity.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=9 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in the Mean Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score at Week 24 for the 15 mg/kg/Day GWP42003-P Dose Level Compared With Placebo Baseline	45.9 units on a scale Standard Deviation 16.77	50.0 units on a scale Standard Deviation 7.56	—
Change From Baseline in the Mean Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score at Week 24 for the 15 mg/kg/Day GWP42003-P Dose Level Compared With Placebo Change from Baseline at Week 24	-12.1 units on a scale Standard Deviation 13.63	-6.1 units on a scale Standard Deviation 7.22	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics (45 items) in individuals with Rett Syndrome. Each item is rated on a 3-point scale (0-2); 0 indicating an item that is "not true as far as you know," 1 indicating an item is "somewhat or sometimes true," and 2 indicating an item that is "very true or often true." Item 31 ("Uses eye gaze to convey feelings, needs and wishes") is reverse scored (0 indicating "very true or often true", 1 indicating "somewhat or sometimes true," and 2 indicating "not true as far as you know"). The total summed score ranges from 0 to 90, with higher scores represent greater severity.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in the Mean RSBQ Total Score at Week 24 for the 5 mg/kg/Day GWP42003-P Dose Level Compared With Placebo Baseline	39.8 units on a scale Standard Deviation 12.80	50.0 units on a scale Standard Deviation 7.56	—
Change From Baseline in the Mean RSBQ Total Score at Week 24 for the 5 mg/kg/Day GWP42003-P Dose Level Compared With Placebo Change from Baseline at Week 24	0.4 units on a scale Standard Deviation 12.51	-6.1 units on a scale Standard Deviation 7.22	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

CGI-I is a 7-point scale that requires the clinician to assess how much a participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention. This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Mean Clinical Global Impressions - Improvement (CGI-I) Score at Week 24	3.2 units on a scale Standard Deviation 1.20	2.9 units on a scale Standard Deviation 1.07	3.1 units on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment relative to the clinician's experience with participants who had the same diagnosis. This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in Mean Clinician Global Impressions - Severity (CGI-S) Score at Week 24 Baseline	4.3 units on a scale Standard Deviation 1.25	4.2 units on a scale Standard Deviation 0.67	4.4 units on a scale Standard Deviation 0.84
Change From Baseline in Mean Clinician Global Impressions - Severity (CGI-S) Score at Week 24 Change from Baseline at Week 24	-0.1 units on a scale Standard Deviation 0.33	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

RSBQ is a caregiver-completed questionnaire that measures the frequency of current disease characteristics in individuals with Rett Syndrome. The 45-item RSBQ is comprised of 8 subscales: 1) general mood (score range 0-16), 2) breathing problems (range 0-10), 3) hand behaviors (range 0-12), 4) face movements (range 0-8), 5) body rocking (BR)/expressionless face (range 0-12), 6) night-time behaviors (range 0-6), 7) anxiety/fear (range 0-8), 8) walking/standing (range 0-4). Each item is rated on a 3-point scale (0-2); 0 indicating an item that is "not true as far as you know," 1 indicating an item is "somewhat or sometimes true," and 2 indicating an item that is "very true or often true." Item 31 ("Uses eye gaze to convey feelings, needs and wishes") is reverse scored (0 indicating "very true or often true", 1 indicating "somewhat or sometimes true," and 2 indicating "not true as far as you know"). Higher scores representing greater severity. CFB = Change from Baseline.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Breathing Problems Score	0.2 units on a scale Standard Deviation 1.86	-1.0 units on a scale Standard Deviation 1.53	-0.3 units on a scale Standard Deviation 1.25
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Breathing Problems Score	4.7 units on a scale Standard Deviation 2.45	5.0 units on a scale Standard Deviation 3.08	5.0 units on a scale Standard Deviation 3.43
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline General Mood Score	6.0 units on a scale Standard Deviation 3.65	8.2 units on a scale Standard Deviation 4.58	8.9 units on a scale Standard Deviation 3.14
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB General Mood Score	-0.6 units on a scale Standard Deviation 2.70	-4.9 units on a scale Standard Deviation 2.67	-2.6 units on a scale Standard Deviation 2.57
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Hand Behaviors Score	7.8 units on a scale Standard Deviation 2.15	7.6 units on a scale Standard Deviation 3.54	9.1 units on a scale Standard Deviation 2.08
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Hand Behaviors Score	0.7 units on a scale Standard Deviation 2.24	-0.9 units on a scale Standard Deviation 3.29	0.1 units on a scale Standard Deviation 0.90
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Face Movements Score	2.3 units on a scale Standard Deviation 2.45	4.6 units on a scale Standard Deviation 2.13	4.3 units on a scale Standard Deviation 2.21
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Face Movements Score	0.0 units on a scale Standard Deviation 1.12	-1.4 units on a scale Standard Deviation 1.72	-0.1 units on a scale Standard Deviation 1.07
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Body Rocking/Expressionless Face Score	4.5 units on a scale Standard Deviation 2.59	5.1 units on a scale Standard Deviation 1.96	5.4 units on a scale Standard Deviation 2.59
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Body Rocking/Expressionless Face Score	0.6 units on a scale Standard Deviation 2.46	-0.6 units on a scale Standard Deviation 1.13	-0.1 units on a scale Standard Deviation 1.86
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Night-time Behaviors Score	0.8 units on a scale Standard Deviation 1.14	0.8 units on a scale Standard Deviation 0.97	1.8 units on a scale Standard Deviation 1.69
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Night-time Behaviors Score	0.2 units on a scale Standard Deviation 0.97	-0.1 units on a scale Standard Deviation 1.46	-0.3 units on a scale Standard Deviation 1.11
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Anxiety/Fear Score	4.0 units on a scale Standard Deviation 1.89	4.6 units on a scale Standard Deviation 2.46	5.1 units on a scale Standard Deviation 1.45
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Anxiety/Fear Score	-0.2 units on a scale Standard Deviation 1.92	-1.3 units on a scale Standard Deviation 2.29	-1.7 units on a scale Standard Deviation 0.95
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 Baseline Walking/Standing Score	2.7 units on a scale Standard Deviation 1.64	2.1 units on a scale Standard Deviation 1.36	2.9 units on a scale Standard Deviation 1.29
Change From Baseline in Mean RSBQ Subscale Scores at Week 24 CFB Walking/Standing Score	0.9 units on a scale Standard Deviation 2.09	0.0 units on a scale Standard Deviation 0.58	0.1 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

MBA-9 is derived from the full MBA scale (37 Rett syndrome symptoms) by selecting the items deemed amenable to change and which reflected areas of meaningful clinical change. the MBA-9 includes 9 items (1-Regression of motor skills; 2-Poor eye/social contact; 3-Lack of sustained interest; 4-Does not reach for objects or people; 5-Chewing difficulties; 6-Speech disturbance; 7-Hand clumsiness; 8-Dystonia and 9-Hypertonia/rigidity); for each item, the severity of current symptoms is rated by the investigator on a 5-point numerical scale ranging from 0 to 4 with higher scores representing greater severity (0 = normal or never; 1 = mild or rare; 2 = moderate or occasional; 3 = marked or frequent; 4 = very severe or constant). Total MBA-9 score was calculated by summing the scores of 9 different subscale items. The total summed score ranges from 0 to 36, with higher scores representing greater severity. CFB = Change from Baseline.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Poor Eye/Social Contact	1.7 units on a scale Standard Deviation 0.82	1.6 units on a scale Standard Deviation 1.01	1.5 units on a scale Standard Deviation 0.97
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Poor Eye/Social Contact	0.0 units on a scale Standard Deviation 0.87	-0.1 units on a scale Standard Deviation 0.69	-0.9 units on a scale Standard Deviation 1.07
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Lack of Sustained Interest	0.0 units on a scale Standard Deviation 0.71	-0.3 units on a scale Standard Deviation 1.11	-0.1 units on a scale Standard Deviation 0.38
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Does Not Reach for Objects or People	2.0 units on a scale Standard Deviation 1.25	1.9 units on a scale Standard Deviation 1.05	2.3 units on a scale Standard Deviation 1.25
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Hypertonia/Rigidity	1.4 units on a scale Standard Deviation 1.51	1.1 units on a scale Standard Deviation 1.45	1.0 units on a scale Standard Deviation 1.41
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB MBA-9 Total Score	0.0 units on a scale Standard Deviation 4.87	-1.9 units on a scale Standard Deviation 4.06	0.0 units on a scale Standard Deviation 3.92
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Regression of Motor Skills	2.2 units on a scale Standard Deviation 1.23	2.6 units on a scale Standard Deviation 0.88	2.6 units on a scale Standard Deviation 0.84
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Regression of Motor Skills	0.3 units on a scale Standard Deviation 1.58	-0.3 units on a scale Standard Deviation 0.49	0.0 units on a scale Standard Deviation 0.58
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Lack of Sustained Interest	1.8 units on a scale Standard Deviation 0.79	2.1 units on a scale Standard Deviation 1.17	1.5 units on a scale Standard Deviation 0.71
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Does Not Reach for Objects or People	-0.4 units on a scale Standard Deviation 2.24	-0.4 units on a scale Standard Deviation 0.98	0.1 units on a scale Standard Deviation 1.21
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Chewing Difficulties	1.3 units on a scale Standard Deviation 1.34	1.3 units on a scale Standard Deviation 0.50	1.1 units on a scale Standard Deviation 0.74
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Chewing Difficulties	-0.2 units on a scale Standard Deviation 0.67	0.0 units on a scale Standard Deviation 0.00	0.4 units on a scale Standard Deviation 0.53
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Speech Disturbance	3.0 units on a scale Standard Deviation 0.47	2.8 units on a scale Standard Deviation 0.83	2.7 units on a scale Standard Deviation 0.48
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Speech Disturbance	0.0 units on a scale Standard Deviation 0.00	0.0 units on a scale Standard Deviation 0.58	0.3 units on a scale Standard Deviation 0.49
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Hand Clumsiness	2.8 units on a scale Standard Deviation 1.14	2.8 units on a scale Standard Deviation 1.56	3.1 units on a scale Standard Deviation 1.10
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Hand Clumsiness	-0.6 units on a scale Standard Deviation 1.33	-0.4 units on a scale Standard Deviation 1.13	0.0 units on a scale Standard Deviation 0.58
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline Dysonia	1.0 units on a scale Standard Deviation 1.41	1.2 units on a scale Standard Deviation 1.56	1.0 units on a scale Standard Deviation 1.41
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Dysonia	0.4 units on a scale Standard Deviation 1.42	-0.1 units on a scale Standard Deviation 0.90	0.1 units on a scale Standard Deviation 1.46
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 CFB Hypertonia/Rigidity	0.4 units on a scale Standard Deviation 0.73	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 1.00
Change From Baseline in Mean 9-items Motor Behavioral Assessment (MBA-9) Total Score and Subscale Scores at Week 24 Baseline MBA-9 Total Score	17.2 units on a scale Standard Deviation 5.81	17.3 units on a scale Standard Deviation 6.78	16.8 units on a scale Standard Deviation 5.96

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Set. Participants with non-missing data were included for analysis.

CSHQ is a caregiver-completed sleep screening instrument designed for school-aged children; which includes 33 items within 8 subscales: 1) bedtime resistance (score range 6-18), 2) sleep onset delay (range 1-3), 3) sleep duration (range 3-9), 4) sleep anxiety (range 4-12), 5) night wakings (range 3-9), 6) parasomnias (range 7-21), 7) sleep-disordered breathing (range 3-9), 8) daytime sleepiness (range 8-24). Item scores range from 1 to 3, where 3="usually" (≥5 times/week), 2="sometimes" (2-4 times/week), and 1="rarely" (≤1 time/week); for items 31 and 32; 3=fall asleep, 2=very sleepy, 1=not sleepy. In general, a score of 3 indicates greater severity, however, 6 items (1-Goes to bed at same time; 2-Falls asleep in 20 minutes; 3-Falls asleep in own bed; 10-Sleeps the right amount; 11-Sleeps same amount each day; 26-Wakes by himself) are reverse scored. Total summed score ranges from 33 to 99, with higher scores representing more disturbed sleep behavior. CFB = Change from Baseline.

Outcome measures

Measure	15 mg/kg/Day GWP42003-P n=10 Participants Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.	Placebo n=10 Participants Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Sleep anxiety	-0.1 units on a scale Standard Deviation 0.78	-0.1 units on a scale Standard Deviation 0.38	0.0 units on a scale Standard Deviation 1.15
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Daytime sleepiness	-0.7 units on a scale Standard Deviation 3.64	-1.4 units on a scale Standard Deviation 2.07	-1.3 units on a scale Standard Deviation 2.56
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Bedtime resistance	0.0 units on a scale Standard Deviation 1.00	-0.4 units on a scale Standard Deviation 1.27	-0.1 units on a scale Standard Deviation 1.68
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Sleep onset delay	1.5 units on a scale Standard Deviation 0.71	1.4 units on a scale Standard Deviation 0.53	1.8 units on a scale Standard Deviation 0.79
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Sleep onset delay	0.1 units on a scale Standard Deviation 1.27	-0.1 units on a scale Standard Deviation 0.69	-0.6 units on a scale Standard Deviation 0.53
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Sleep duration	4.7 units on a scale Standard Deviation 2.41	3.4 units on a scale Standard Deviation 0.73	4.5 units on a scale Standard Deviation 1.58
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Sleep duration	0.4 units on a scale Standard Deviation 1.13	-0.3 units on a scale Standard Deviation 0.95	-0.4 units on a scale Standard Deviation 1.72
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Sleep anxiety	5.6 units on a scale Standard Deviation 1.65	4.6 units on a scale Standard Deviation 0.73	4.9 units on a scale Standard Deviation 1.10
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Night wakings	5.3 units on a scale Standard Deviation 2.36	4.4 units on a scale Standard Deviation 1.33	4.6 units on a scale Standard Deviation 1.43
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Night wakings	-0.4 units on a scale Standard Deviation 0.88	-0.6 units on a scale Standard Deviation 1.40	0.1 units on a scale Standard Deviation 0.69
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Parasomnias	11.0 units on a scale Standard Deviation 1.49	10.4 units on a scale Standard Deviation 1.42	11.7 units on a scale Standard Deviation 2.63
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Parasomnias	-0.6 units on a scale Standard Deviation 1.51	-1.1 units on a scale Standard Deviation 1.68	-1.4 units on a scale Standard Deviation 2.30
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Sleep disordered breathing	4.2 units on a scale Standard Deviation 1.69	4.0 units on a scale Standard Deviation 1.22	3.7 units on a scale Standard Deviation 1.06
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Sleep disordered breathing	-0.4 units on a scale Standard Deviation 1.74	-0.9 units on a scale Standard Deviation 1.07	-0.1 units on a scale Standard Deviation 0.38
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Daytime sleepiness	11.6 units on a scale Standard Deviation 3.20	13.2 units on a scale Standard Deviation 2.39	13.7 units on a scale Standard Deviation 2.50
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Total Score	49.8 units on a scale Standard Deviation 9.75	46.7 units on a scale Standard Deviation 4.90	49.4 units on a scale Standard Deviation 5.42
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 CFB Total score	-1.6 units on a scale Standard Deviation 6.17	-5.0 units on a scale Standard Deviation 6.14	-3.7 units on a scale Standard Deviation 4.07
Change From Baseline in Mean Children's Sleep Habits Questionnaire (CSHQ) Total Score and Subscale Scores at Week 24 Baseline Bedtime resistance	9.2 units on a scale Standard Deviation 3.43	7.3 units on a scale Standard Deviation 2.12	7.0 units on a scale Standard Deviation 1.25

Adverse Events

5 mg/kg/Day GWP42003-P

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

15 mg/kg/Day GWP42003-P

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	5 mg/kg/Day GWP42003-P n=11 participants at risk Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).	15 mg/kg/Day GWP42003-P n=9 participants at risk Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 participants at risk Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Infections and infestations COVID-19	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Lower respiratory tract infection	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Alanine aminotransferase increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Dyskinesia	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.

Other adverse events

Measure	5 mg/kg/Day GWP42003-P n=11 participants at risk Participants received 5 milligrams (mg)/kilogram (kg)/day GWP42003-P, administered as 100 mg/milliliter (mL) oral solution twice daily (BID).	15 mg/kg/Day GWP42003-P n=9 participants at risk Participants received 15 mg/kg/day GWP42003-P, administered as 100 mg/mL oral solution BID.	Placebo n=9 participants at risk Participants received placebo oral solution matched to 5 or 15 mg/kg/day GWP42003-P, BID.
Investigations Breath sounds abnormal	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Gamma-glutamyltransferase increased	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Mean cell volume increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	22.2% 2/9 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Metabolism and nutrition disorders Hypoglycaemia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Metabolism and nutrition disorders Selenium deficiency	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Musculoskeletal and connective tissue disorders Joint stiffness	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Balance disorder	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Disturbance in attention	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Dizziness postural	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Drooling	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Hyperreflexia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Lethargy	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	33.3% 3/9 • Number of events 3 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Seizure	9.1% 1/11 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Nervous system disorders Somnolence	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Agitation	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Anxiety	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Bruxism	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Dermatillomania	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	22.2% 2/9 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Irritability	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Middle insomnia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Nervousness	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Psychiatric disorders Sleep disorder	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Respiratory, thoracic and mediastinal disorders Choking	9.1% 1/11 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Skin and subcutaneous tissue disorders Alopecia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Skin and subcutaneous tissue disorders Skin discolouration	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Blood and lymphatic system disorders Coagulopathy	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Blood and lymphatic system disorders Macrocytosis	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Blood and lymphatic system disorders Neutropenia	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Eye disorders Ocular hyperaemia	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Diarrhoea	18.2% 2/11 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	22.2% 2/9 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Faeces soft	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Tooth discolouration	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Gastrointestinal disorders Vomiting	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	22.2% 2/9 • Number of events 3 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
General disorders Fatigue	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
General disorders Pyrexia	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	22.2% 2/9 • Number of events 3 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Gastroenteritis	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Nasopharyngitis	18.2% 2/11 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 2 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Otitis media	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Pharyngitis streptococcal	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	33.3% 3/9 • Number of events 5 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Infections and infestations Viral upper respiratory tract infection	9.1% 1/11 • Number of events 4 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Injury, poisoning and procedural complications Sunburn	9.1% 1/11 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Alanine aminotransferase increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/11 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	11.1% 1/9 • Number of events 1 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.	0.00% 0/9 • Up to approximately 207 days Safety Analysis Set: All participants who received at least 1 dose of investigational medicinal product in the trial were included and analyzed according to the treatment received. One participant who was assigned to the placebo group received GWP42003-P 5 mg/kg. For safety analyses, this participant was assigned to the GWP42003-P 5 mg/kg group.

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