Trial Outcomes & Findings for A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) (NCT NCT02544763)

NCT ID: NCT02544763

Last Updated: 2022-09-28

Results Overview

TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 224 participants
• Primary outcome timeframe: Baseline; up to Week 16
• Results posted on: 2022-09-28

Participant Flow

A total of 255 participants were screened; 31 of whom were screen failures. A total of 224 participants were randomized to double-blind treatment.

Participant milestones

Measure	GWP42003-P 25 mg/kg/Day Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Overall Study STARTED	75	73	76
Overall Study COMPLETED	65	61	75
Overall Study NOT COMPLETED	10	12	1

Reasons for withdrawal

Measure	GWP42003-P 25 mg/kg/Day Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Overall Study Adverse Event	8	8	0
Overall Study Withdrawn by parent/guardian	1	1	1
Overall Study Met withdrawal criteria	0	2	0
Overall Study Physician Decision	0	1	0
Overall Study Difficulties taking IMP	1	0	0

Baseline Characteristics

Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.

Baseline characteristics by cohort

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.	Total n=224 Participants Total of all reporting groups
Age, Continuous	14.112 years STANDARD_DEVIATION 10.8131 • n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	12.915 years STANDARD_DEVIATION 8.5324 • n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	13.918 years STANDARD_DEVIATION 10.6302 • n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	13.659 years STANDARD_DEVIATION 10.0324 • n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Sex: Female, Male Female	32 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	30 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	31 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	93 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Sex: Female, Male Male	43 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	42 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	44 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	129 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized White/Caucasian	68 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	65 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	66 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	199 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Black/African American	2 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	3 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	5 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Asian	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	3 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	4 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Biracial Causasian-African American	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Latin	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Arabic	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Caucasian/Asian	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	2 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	2 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Hispanic	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	3 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	4 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Hispanic And Caucasian	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Anglo Indian	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Race/Ethnicity, Customized Black, White, American Indian	0 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	0 Participants n=72 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=75 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.	1 Participants n=222 Participants • Two participants were excluded from the summary of demographic data because their heights at screening were measured in inches but were recorded in centimeters.
Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures	77.95 seizures STANDARD_DEVIATION 83.390 • n=75 Participants • Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with IMP in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized.	92.95 seizures STANDARD_DEVIATION 89.782 • n=73 Participants • Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with IMP in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized.	89.22 seizures STANDARD_DEVIATION 101.778 • n=76 Participants • Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with IMP in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized.	86.66 seizures STANDARD_DEVIATION 91.841 • n=224 Participants • Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with IMP in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized.
Number of Total Seizures	80.87 seizures STANDARD_DEVIATION 84.676 • n=75 Participants • ITT Analysis Set	108.06 seizures STANDARD_DEVIATION 115.699 • n=73 Participants • ITT Analysis Set	118.32 seizures STANDARD_DEVIATION 211.868 • n=76 Participants • ITT Analysis Set	102.44 seizures STANDARD_DEVIATION 148.495 • n=224 Participants • ITT Analysis Set

PRIMARY outcome

Timeframe: Baseline; up to Week 16

Population: Intent-to-Treat (ITT) Analysis Set: all participants who were randomized and dosed with investigational medicinal product (IMP) in the trial and had post-Baseline efficacy data. Participant data were analyzed according to the treatment group to which they were randomized.

TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100.

Outcome measures

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Percent Change From Baseline in the Number of Tuberous Sclerosis Complex (TSC)-Associated Seizures During the Treatment Period (Maintenance and Titration)	-43.36 percent change Interval -67.8 to -13.6	-36.55 percent change Interval -67.0 to -5.5	-20.08 percent change Interval -47.1 to 3.1

SECONDARY outcome

Timeframe: Baseline; up to Week 16

Population: ITT Analysis Set

Treatment responders are defined as those participants with a ≥ 50% reduction in TSC-associated seizure frequency. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that are countable. Participants who withdrew from the trial during the treatment period are considered non-responders.

Outcome measures

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) Responders	27 Participants	29 Participants	17 Participants
Number of Participants Considered Treatment Responders During the Treatment Period (Maintenance and Titration) Non-responders	48 Participants	44 Participants	59 Participants

SECONDARY outcome

Timeframe: Baseline; up to Week 16

Population: ITT Analysis Set. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

The combined caregiver and participant summary uses either the caregiver or participant version if only one version was completed, or the caregiver version if both caregiver and participant versions were completed. The CGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)." The SGIC comprised the following question, to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)."

Outcome measures

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit Caregiver	3.0 units on a scale Standard Deviation 1.34	3.1 units on a scale Standard Deviation 1.40	3.5 units on a scale Standard Deviation 0.93
Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit Combined Caregiver and Participant	3.0 units on a scale Standard Deviation 1.35	3.2 units on a scale Standard Deviation 1.45	3.5 units on a scale Standard Deviation 0.96
Change From Baseline in the Caregiver Global Impression of Change (CGIC) or Participant Global Impression of Change (PGIC) Score at the Participant's Last Visit Participant	3.3 units on a scale Standard Deviation 1.51	4.5 units on a scale Standard Deviation 1.73	2.8 units on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: Baseline; up to Week 16

Population: ITT Analysis Set

Total seizures included all seizure types combined. Percent change from Baseline was calculated as the (post-Baseline value minus the Baseline value) divided by the Baseline value x 100.

Outcome measures

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Percent Change From Baseline in Total Seizures During the Treatment Period (Maintenance and Titration)	-34.71 percent change Standard Deviation 46.150	-35.14 percent change Standard Deviation 42.530	-19.63 percent change Standard Deviation 35.137

SECONDARY outcome

Timeframe: up to approximately Week 22

Population: Safety Analysis Set: all participants randomized to treatment who received at least 1 dose of IMP

A TEAE was defined as an AE with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of first dose of the Open-label Extension (OLE) Phase (OLE Day 1).

Outcome measures

Measure	GWP42003-P 25 mg/kg/Day n=75 Participants Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 Participants Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 Participants Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Number of Participants With Any Severe Treatment-emergent Adverse Event (TEAE)	7 Participants	9 Participants	1 Participants

Adverse Events

GWP42003-P 25 mg/kg/Day

Serious events: 16 serious events

Other events: 66 other events

Deaths: 0 deaths

GWP42003-P 50 mg/kg/Day

Serious events: 10 serious events

Other events: 71 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Measure	GWP42003-P 25 mg/kg/Day n=75 participants at risk Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 participants at risk Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 participants at risk Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Investigations Transaminases increased	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Vomiting	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Abdominal pain	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Diarrhoea	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Nausea	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
General disorders Fatigue	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
General disorders Malaise	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Hepatobiliary disorders Liver injury	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Immune system disorders Type IV hypersensitivity reaction	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Gastroenteritis viral	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Pneumonia	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Gastroenteritis	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Otitis media acute	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Injury, poisoning and procedural complications Laceration	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Alanine aminotransferase increased	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Aspartate aminotransferase increased	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Blood bilirubin increased	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Dehydration	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Electrolyte imbalance	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Hypophagia	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Status epilepticus	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Seizure	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Rash	1.3% 1/75 • Number of events 1 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Rash erythematous	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).

Other adverse events

Measure	GWP42003-P 25 mg/kg/Day n=75 participants at risk Participants were randomized to receive GWP42003-P 25 milligrams per kilogram per day (mg/kg/day) (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	GWP42003-P 50 mg/kg/Day n=73 participants at risk Participants were randomized to receive GWP42003-P 50 mg/kg/day (via oral twice daily \[morning and evening\] administration). Participants completed a 4-week dose escalation period, titrating up to their assigned dose, before continuing on a stable dose of blinded GWP42003-P for 12 weeks.	Placebo n=76 participants at risk Participants were randomized to receive placebo matched to GWP42003-P (via oral twice daily \[morning and evening\] administration) for 16 weeks.
Blood and lymphatic system disorders Anaemia	6.7% 5/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Ear and labyrinth disorders Ear pain	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Constipation	10.7% 8/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.8% 5/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	7.9% 6/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Diarrhoea	30.7% 23/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	54.8% 40/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	25.0% 19/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Frequent bowel movements	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Nausea	8.0% 6/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Retching	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Gastrointestinal disorders Vomiting	16.0% 12/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	17.8% 13/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	9.2% 7/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
General disorders Fatigue	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	5.5% 4/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
General disorders Gait disturbance	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
General disorders Pyrexia	18.7% 14/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	16.4% 12/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	7.9% 6/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Bronchitis	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Ear infection	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	5.5% 4/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Gastroenteritis	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Gastroenteritis viral	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	3.9% 3/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Nasopharyngitis	14.7% 11/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	15.1% 11/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	15.8% 12/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Otitis media	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Pharyngitis	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Pharyngitis streptococcal	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Pneumonia	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Respiratory tract infection	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Tonsillitis	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Upper respiratory tract infection	9.3% 7/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	9.6% 7/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	13.2% 10/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Urinary tract infection	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Infections and infestations Viral infection	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Injury, poisoning and procedural complications Fall	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	5.5% 4/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Injury, poisoning and procedural complications Laceration	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Injury, poisoning and procedural complications Ligament sprain	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Alanine aminotransferase increased	9.3% 7/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	19.2% 14/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Anticonvulsant drug level increased	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Aspartate aminotransferase increased	8.0% 6/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	16.4% 12/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Eosinophil count increased	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Gamma-glutamyltransferase increased	16.0% 12/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	13.7% 10/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Hepatic enzyme increased	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations International normalised ratio increased	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Platelet count decreased	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Prothrombin time prolonged	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Investigations Weight decreased	6.7% 5/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	8.2% 6/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Decreased appetite	20.0% 15/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	23.3% 17/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	11.8% 9/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Diet refusal	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Metabolism and nutrition disorders Increased appetite	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Ataxia	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Dizziness	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	3.9% 3/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Drooling	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Headache	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	5.3% 4/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Hypersomnia	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Lethargy	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Seizure	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	9.6% 7/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Nervous system disorders Somnolence	13.3% 10/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	26.0% 19/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	9.2% 7/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Abnormal behaviour	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Aggression	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	3.9% 3/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Agitation	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	3.9% 3/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Anxiety	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Insomnia	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Irritability	5.3% 4/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.8% 5/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	5.3% 4/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Psychiatric disorders Panic attack	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Asthma	1.3% 1/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Cough	10.7% 8/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	6.6% 5/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.7% 2/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	4.1% 3/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Respiratory, thoracic and mediastinal disorders Throat irritation	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Dermatitis diaper	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.3% 1/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Pruritus	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Skin and subcutaneous tissue disorders Rash	4.0% 3/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	9.6% 7/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	2.6% 2/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).
Vascular disorders Hypertension	2.7% 2/75 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	1.4% 1/73 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).	0.00% 0/76 • up to approximately Week 22 Baseline data are reported for members of the Safety Analysis Set, comprised of participants randomized to treatment who received at least 1 dose of investigational medicinal product (IMP). Treatment-emergent adverse events are defined as adverse events with a start date on or after the first dose of IMP during the Blinded Phase up to and including the date of the first dose of the Open-label Extension (OLE) Phase (OLE Day 1).

Additional Information

Medical Enquiries

GW Research Ltd

Phone: +1 833 424 6724

Email: medinfo@gwpharm.com; medinfo@greenwichbiosciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60