Trial Outcomes & Findings for An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes (NCT NCT02224573)

NCT ID: NCT02224573

Last Updated: 2022-02-03

Results Overview

TEAEs, defined as AEs that started, or worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, are reported. Any AEs that continued from the Core Study (GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], GWEP1424 \[NCT02224703\], GWEP1414 \[NCT02224560\], and GWEP1423 \[NCT02224690\]) were only classified as treatment emergent if they worsened in this study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 681 participants
• Primary outcome timeframe: up to Week 260
• Results posted on: 2022-02-03

Participant Flow

Participants who completed the double-blind, placebo-controlled, clinical studies with GWP42003-P (Core Studies: GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were eligible for enrollment.

Participant milestones

Measure	Dravet Syndrome Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Treatment Phase STARTED	315	366
Treatment Phase COMPLETED	170	243
Treatment Phase NOT COMPLETED	145	123
Taper Phase STARTED	79	71
Taper Phase COMPLETED	76	67
Taper Phase NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Dravet Syndrome Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Treatment Phase Caregiver Asked to Stop Investigational Medicinal Product (IMP)	0	1
Treatment Phase Started on Other IMP	1	0
Treatment Phase Participant Discontinued IMP	0	1
Treatment Phase Lack of Efficacy	15	8
Treatment Phase Began Commercial Product	1	0
Treatment Phase Lack of Efficacy per Participant/Caregiver	3	3
Treatment Phase Met Withdrawal Criteria	5	7
Treatment Phase Participant Did Not Return for Visits	0	1
Treatment Phase Continued Compassionate Use	1	0
Treatment Phase Lack of Efficiency	2	1
Treatment Phase Participant with Protocol-Excluded Treatment	0	1
Treatment Phase Participant Moved	2	0
Treatment Phase Withdrawal by Participant or Parent/Guardian	62	48
Treatment Phase Refused Medication	1	1
Treatment Phase Adverse Event	26	38
Treatment Phase Placed in Group Home	0	1
Treatment Phase Pursued Other Trials	1	0
Treatment Phase Withdrawn by the Investigator	23	11
Treatment Phase Lost to Follow-up	2	1
Taper Phase Completed Incorrect Number of Taper Days	1	0
Taper Phase Hospitalization/Dose Reduction	1	0
Taper Phase Withdrawn by participants or parent/guardian	0	3
Taper Phase Adverse Event	1	1

Baseline Characteristics

An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

Baseline characteristics by cohort

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Total n=681 Participants Total of all reporting groups
Sex: Female, Male Female	159 Participants n=5 Participants	168 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	198 Participants n=7 Participants	354 Participants n=5 Participants
Age, Continuous	9.737 years STANDARD_DEVIATION 4.4434 • n=5 Participants	15.906 years STANDARD_DEVIATION 9.5392 • n=7 Participants	13.053 years STANDARD_DEVIATION 8.2120 • n=5 Participants
Age, Customized Children (2-11 years)	216 Participants n=5 Participants	157 Participants n=7 Participants	373 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	90 Participants n=5 Participants	89 Participants n=7 Participants	179 Participants n=5 Participants
Age, Customized Adults (18-64 years)	9 Participants n=5 Participants	120 Participants n=7 Participants	129 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	269 Participants n=5 Participants	325 Participants n=7 Participants	594 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	16 Participants n=7 Participants	45 Participants n=5 Participants
Race White/Caucasian	269 Participants n=5 Participants	325 Participants n=7 Participants	594 Participants n=5 Participants
Race Black/African American	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race American Indian/Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race Not Applicable (As per country-specific data protection law.	15 Participants n=5 Participants	1 Participants n=7 Participants	16 Participants n=5 Participants
Race Caucasian/Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race Hispanic/Caucasian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race White and Black Caribbean	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race Biracial	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race Caucasian and African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race Mulatto	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race North African	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race South American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race Eurasian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race Anglo-Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race Indian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race Arab	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set: all participants who received at least 1 dose of investigational medicinal product (IMP).

TEAEs, defined as AEs that started, or worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, are reported. Any AEs that continued from the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) were only classified as treatment emergent if they worsened in this study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Total participants affected by any TEAE	306 participants	353 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Diarrhoea	135 participants	140 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Vomiting	63 participants	107 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Constipation	20 participants	43 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Nausea	16 participants	32 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Pyrexia	124 participants	126 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Fatigue	39 participants	38 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Upper respiratory tract infection	78 participants	104 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Nasopharyngitis	78 participants	58 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Sinusitis	38 participants	49 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Pneumonia	35 participants	51 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Ear infection	35 participants	50 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Gamma-glutamyltransferase increased	32 participants	20 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Decreased appetite	99 participants	93 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Convulsion	79 participants	141 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Influenza	37 participants	45 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Urinary tract infection	19 participants	51 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Pharyngitis streptococcal	26 participants	27 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Gastroenteritis viral	15 participants	30 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Otitis media	21 participants	22 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Bronchitis	15 participants	23 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Viral upper respiratory tract infection	11 participants	20 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Gastroenteritis	16 participants	7 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Fall	22 participants	23 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Laceration	8 participants	35 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Contusion	15 participants	25 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Weight decreased	21 participants	61 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Alanine aminotransferase increased	37 participants	30 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Aspartate aminotransferase increased	38 participants	19 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Somnolence	87 participants	107 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Status epilepticus	47 participants	42 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Lethargy	21 participants	34 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Headache	18 participants	26 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Sedation	16 participants	27 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Drooling	11 participants	21 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Abnormal behaviour	34 participants	23 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Insomnia	16 participants	40 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Irritability	26 participants	29 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Aggression	20 participants	30 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Agitation	9 participants	19 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Cough	42 participants	63 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Nasal congestion	13 participants	46 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Rhinorrhoea	20 participants	19 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Pneumonia aspiration	4 participants	22 participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Occurring in ≥5% of Participants in Any Treatment Group Hypoxia	2 participants	21 participants

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set

Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. bpm = beats per minute; DBP = Diastolic Blood Pressure; mmHg = millimeters of mercury; SBP = Systolic Blood Pressure. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Sitting SBP < -20 mmHg	59 participants	88 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Sitting SBP > 20 mmHg	96 participants	120 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Sitting DBP < -10 mmHg	139 participants	176 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Sitting DBP > 10 mmHg	166 participants	191 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Pulse Rate < -15 bpm	176 participants	192 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Pulse Rate > 15 bpm	150 participants	179 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Weight ≤ -7 %	47 participants	106 participants
Number of Participants With Clinically Significant Changes in the Indicated Vital Sign Values From the Pre-randomization Baseline of the Core Study at Any Time Post-dose Weight ≥ 7%	213 participants	223 participants

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

BMI is an estimate of body fat based on body weight divided by height squared. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=243 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=294 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Body Mass Index (BMI)	0.42 kilograms per meters squared (kg/m^2) Standard Deviation 2.701	0.05 kilograms per meters squared (kg/m^2) Standard Deviation 5.863

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set

Clinical significance was determined by the investigator. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. msec = milliseconds; QTcB = corrected QT interval with Bazett's correction. The time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 450 msec, Baseline	13 participants	21 participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 450 msec, any time post-dose	62 participants	120 participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 480 msec, Baseline	2 participants	4 participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 480 msec, any time post-dose	10 participants	40 participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 500 msec, Baseline	2 participants	2 participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Values at the Pre-randomization Baseline of the Core Study and at Any Time Post-dose QTcB > 500 msec, any time post-dose	7 participants	20 participants

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set

The C-SSRS questionnaire is a brief, standardized measure that uniquely assesses the essential information (behavior, ideation, lethality, and severity) and distinguishes between suicidal occurrences and non-suicidal self-injury.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Any suicidality, Day 1	1 participants	1 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Any suicidality, any time post-dose	1 participants	2 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Suicidal ideation, Day 1	0 participants	1 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Suicidal ideation, any time post-dose	1 participants	2 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Suicidal behavior, Day 1	1 participants	0 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Suicidal behavior, any time post-dose	1 participants	0 participants
Number of Participants With the Indicated Responses to Questions Regarding Suicidal Ideation and Behavior Using the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 1 and at Any Time Post-dose Complete suicidality, any time post-dose	0 participants	0 participants

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants (18 years and above) with available Cannabis Withdrawal Scale score were analyzed.

The Cannabis Withdrawal Scale is a 19-item scale administered to participants (18 years and above), with each item (withdrawal symptom) measured on a 0 to 10 numerical rating scale (0 = Not at all; 5 = Moderately; 10 = Extremely). Total score, calculated as the sum of the 19 item sub-scores ranging from 0-190 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. L24S = Last 24 Hours Score; NIS = Negative Impact on Normal Daily Activity Score. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up L24S, End of Taper	9.8 scores on a scale Standard Deviation 10.64	4.9 scores on a scale Standard Deviation 14.00
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up L24S, Post-Taper Safety Call	3.4 scores on a scale Standard Deviation 4.72	0.0 scores on a scale Standard Deviation 0.00
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up L24S, Safety Follow-Up	2.4 scores on a scale Standard Deviation 3.36	4.9 scores on a scale Standard Deviation 12.27
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up NIS, End of Taper	9.5 scores on a scale Standard Deviation 12.03	5.1 scores on a scale Standard Deviation 10.96
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up NIS, Post-Taper Safety Call	16.3 scores on a scale Standard Deviation 3.79	1.2 scores on a scale Standard Deviation 3.00
Mean Cannabis Withdrawal Scale Score at End of Taper (EOT), the Post-Taper Safety Call, and at Safety Follow-up NIS, Safety Follow-Up	5.3 scores on a scale Standard Deviation 9.24	1.8 scores on a scale Standard Deviation 3.82

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants (4 to 17 years) with available Pediatric Cannabis Withdrawal Scale score were analyzed.

The PCWS was administered to participants aged 4 to 17 (inclusive) that was developed from the 19-item validated CWS (adults) to assess mood, behavioral, and physical symptoms associated with cannabis. The total score, calculated as the sum of 10 items (rated on a 4-point scale: 0 = none; 1 = a little bit; 2 = quite a bit; 3 = a lot) ranging from 0-30 are reported. Higher scores indicate more withdrawal symptoms and an increased negative impact to quality of life. The End of Treatment visit occurred after a maximum of 260 weeks of treatment. The participant or participant's caregiver was asked to record the extent to which each withdrawal symptom was experienced in the last 24 hours and also to rate the negative impact on normal daily activities. The End of Taper occurred up to 10 days after the End of Treatment visit. The Safety Call and Safety Follow-up occurred 2 and 4 weeks, respectively, after the End of Taper.

Outcome measures

Measure	Dravet Syndrome n=74 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=46 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up End of Treatment	4.0 scores on a scale Standard Deviation NA Only 1 participant was analyzed so SD could not be evaluated.	6.0 scores on a scale Standard Deviation NA Only 1 participant was analyzed so SD could not be evaluated.
Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up End of Taper	2.9 scores on a scale Standard Deviation 3.77	2.1 scores on a scale Standard Deviation 2.78
Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up Post-Taper Safety Call	2.4 scores on a scale Standard Deviation 3.50	2.0 scores on a scale Standard Deviation 2.72
Mean Pediatric Cannabinoid Withdrawal Scale (PCWS) Score at the End of Treatment, the End of Taper, the Post-Taper Safety Call, and at Safety Follow-up Safety Follow-Up	1.9 scores on a scale Standard Deviation 2.72	1.8 scores on a scale Standard Deviation 2.28

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=307 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Red Blood Cells (RBCs) Values	-0.068 10^12 cells per Liter (L) Standard Deviation 0.3297	-0.059 10^12 cells per Liter (L) Standard Deviation 0.3424

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=307 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hemoglobin Levels	-1.6 grams per Liter (g/L) Standard Deviation 9.08	-2.4 grams per Liter (g/L) Standard Deviation 11.14

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=307 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Hematocrit Values	-0.0105 percentage of RBCs in whole blood (L/L) Standard Deviation 0.02938	-0.0110 percentage of RBCs in whole blood (L/L) Standard Deviation 0.02983

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=307 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Volume	-1.0 femtoliters (fL) Standard Deviation 5.10	-1.3 femtoliters (fL) Standard Deviation 5.01

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=307 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Erythrocyte Mean Corpuscular Hemoglobin	0.10 picograms (pg) Standard Deviation 1.482	-0.15 picograms (pg) Standard Deviation 1.926

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Platelets	5.4 10^9 cells/L Standard Deviation 64.84	5.0 10^9 cells/L Standard Deviation 70.47
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils White blood cells	-0.52 10^9 cells/L Standard Deviation 2.531	-0.09 10^9 cells/L Standard Deviation 2.052
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Basophils	0.00 10^9 cells/L Standard Deviation 0.041	0.01 10^9 cells/L Standard Deviation 0.040
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Eosinophils	-0.02 10^9 cells/L Standard Deviation 0.159	-0.02 10^9 cells/L Standard Deviation 0.165
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Lymphocytes	-0.31 10^9 cells/L Standard Deviation 0.988	-0.14 10^9 cells/L Standard Deviation 0.778
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Monocytes	-0.05 10^9 cells/L Standard Deviation 0.276	0.01 10^9 cells/L Standard Deviation 0.245
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils Neutrophils	-0.16 10^9 cells/L Standard Deviation 2.041	0.05 10^9 cells/L Standard Deviation 1.878

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=268 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=305 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) Basophils/WBCs	0.08 percentage in WBCs Standard Deviation 0.284	0.12 percentage in WBCs Standard Deviation 0.287
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) Eosinophils/WBCs	-0.10 percentage in WBCs Standard Deviation 2.064	-0.24 percentage in WBCs Standard Deviation 2.104
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) Lymphocytes/WBCs	-1.32 percentage in WBCs Standard Deviation 12.396	-1.32 percentage in WBCs Standard Deviation 11.193
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) Monocytes/WBCs	-0.05 percentage in WBCs Standard Deviation 3.125	0.18 percentage in WBCs Standard Deviation 2.600
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils in White Blood Cells (WBCs) Neutrophils/WBCs	1.47 percentage in WBCs Standard Deviation 12.982	1.27 percentage in WBCs Standard Deviation 12.245

PRIMARY outcome

Timeframe: up to week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol Glucose	-0.06 millimoles per Liter (mmol/L) Standard Deviation 1.026	0.06 millimoles per Liter (mmol/L) Standard Deviation 1.288
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol Sodium	-0.4 millimoles per Liter (mmol/L) Standard Deviation 3.25	-0.8 millimoles per Liter (mmol/L) Standard Deviation 2.70
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol Potassium	-0.06 millimoles per Liter (mmol/L) Standard Deviation 0.372	-0.08 millimoles per Liter (mmol/L) Standard Deviation 0.407
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol Blood urea nitrogen	-0.08 millimoles per Liter (mmol/L) Standard Deviation 1.571	0.00 millimoles per Liter (mmol/L) Standard Deviation 1.555
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol Calcium	-0.050 millimoles per Liter (mmol/L) Standard Deviation 0.1148	-0.054 millimoles per Liter (mmol/L) Standard Deviation 0.1218
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Sodium, Potassium, Blood Urea Nitrogen, Glucose, Calcium, and High-Density Lipoprotein (HDL) Cholesterol HDL cholesterol	0.06 millimoles per Liter (mmol/L) Standard Deviation 0.372	0.12 millimoles per Liter (mmol/L) Standard Deviation 0.320

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin Creatinine, Jaffe	7.0 micromoles per Liter (µmol/L) Standard Deviation 9.32	7.1 micromoles per Liter (µmol/L) Standard Deviation 10.86
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin Creatinine, enzymatic	3.8 micromoles per Liter (µmol/L) Standard Deviation 8.83	4.0 micromoles per Liter (µmol/L) Standard Deviation 9.44
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine (Jaffe), Creatinine (Enzymatic), and Bilirubin Bilirubin	0.48 micromoles per Liter (µmol/L) Standard Deviation 2.339	0.45 micromoles per Liter (µmol/L) Standard Deviation 2.626

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. mL/min/1.73 m^2 = millilitres per minute per 1.73 meters squared. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault) Creatinine Clearance, Schwartz,	0.3 mL/min/1.73 m^2 Standard Deviation 4.41	0.0 mL/min/1.73 m^2 Standard Deviation 0.00
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Creatinine Clearance (Schwartz) and Creatinine Clearance (Cockcroft-Gault) Creatinine Clearance, Cockcroft-Gault	0.0 mL/min/1.73 m^2 Standard Deviation 0.00	-0.6 mL/min/1.73 m^2 Standard Deviation 5.94

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase Gamma glutamyl transferase	8.7 Units/L Standard Deviation 42.35	4.9 Units/L Standard Deviation 45.65
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase Alkaline phosphatase	-40.9 Units/L Standard Deviation 88.18	-40.1 Units/L Standard Deviation 73.62
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase Aspartate aminotransferase	4.0 Units/L Standard Deviation 26.14	2.8 Units/L Standard Deviation 26.62
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, and Gamma Glutamyl Transferase Alanine aminotransferase	7.0 Units/L Standard Deviation 39.24	9.5 Units/L Standard Deviation 43.96

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein Albumin	-0.2 grams (g)/L Standard Deviation 3.43	-0.9 grams (g)/L Standard Deviation 3.31
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Albumin and Protein Protein	-1.2 grams (g)/L Standard Deviation 5.83	-2.0 grams (g)/L Standard Deviation 5.75

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=276 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=309 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prolactin	0.43 µInternational Units/millilitre (µIU/mL) Standard Deviation 132.613	10.43 µInternational Units/millilitre (µIU/mL) Standard Deviation 230.439

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=256 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=282 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin Time	-0.08 seconds Standard Deviation 0.740	-0.09 seconds Standard Deviation 0.706

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=256 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=282 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Prothrombin International Normalized Ratio	-0.012 ratio Standard Deviation 0.0784	-0.010 ratio Standard Deviation 0.0736

PRIMARY outcome

Timeframe: up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

IGF-1 levels in serum were analyzed as part of the clinical laboratory testing in participants. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=69 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=142 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Insulin-like Growth Factor-1 (IGF-1) Levels	-0.28 nanomoles (nmol)/L Standard Deviation 12.701	1.10 nanomoles (nmol)/L Standard Deviation 15.970

PRIMARY outcome

Timeframe: Baseline; up to Week 260

Population: Safety Analysis Set. Only those participants with available data were analyzed.

The S/CGIC allows participants and caregivers to rate the participant's overall condition on a scale of 1 to 7 (1 = Very Much Improved, and 7 = Very Much Worse). The combined caregiver and participant summary used either the caregiver or participant version if only one version was completed, or the caregiver version when both the caregiver and participant versions were completed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Subject/Caregiver Global Impression of Change (S/CGIC) Score	3.0 Scores on a scale Standard Deviation 1.47	2.8 Scores on a scale Standard Deviation 1.38

PRIMARY outcome

Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Population: Safety Analysis Set. Only participants with available data were analyzed.

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Last 12 weeks	-55.2 percentage change Interval -84.0 to 2.9	-51.9 percentage change Interval -84.7 to -13.3
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Week 49 to 60	-65.8 percentage change Interval -86.9 to -19.8	-58.9 percentage change Interval -84.6 to -26.9
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Week 97 to 108	-71.3 percentage change Interval -93.8 to -14.3	-66.4 percentage change Interval -86.2 to -34.2
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Week 145 to 156	-79.8 percentage change Interval -97.6 to -5.3	-65.3 percentage change Interval -88.2 to -32.0
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Week 205 to 216	-81.5 percentage change Interval -93.0 to -73.3	-78.4 percentage change Interval -94.3 to -52.4
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Total Seizure Frequency Week 253 to 264	-70.0 percentage change Interval -83.1 to 178.6	—

PRIMARY outcome

Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, and Last 12 Weeks

Population: Safety Analysis Set. Only participants with available data were analyzed.

Drop seizures are defined as the subset of tonic-clonic, tonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

Outcome measures

Measure	Dravet Syndrome n=366 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome Week 49 to 60	-59.4 percentage change Interval -85.9 to -22.5	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome Week 97 to 108	-69.4 percentage change Interval -91.3 to -27.9	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome Week 145 to 156	-70.8 percentage change Interval -90.8 to -37.5	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome Week 205 to 216	-68.7 percentage change Interval -98.8 to -33.3	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Drop Seizure Frequency in Participants With Lennox-Gastaut Syndrome Last 12 weeks	-59.4 percentage change Interval -87.1 to -15.4	—

PRIMARY outcome

Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Population: Safety Analysis Set. Only participants with available data were analyzed.

Convulsive seizures are defined as tonic-clonic, tonic, clonic, or atonic seizures. Change from Baseline was calculated as the percentage change from Baseline for each 12-week period. Pre-randomization Baseline of the Core Study (GWEP1332A [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560], and GWEP1423 [NCT02224690]) is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. Data for change from Baseline at pre-randomization of the Core Study are presented; however, the time frame represents the duration for which participants were enrolled in GWEP1415. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Dravet Syndrome participants only. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Week 49 to 60	-52.9 percentage change Interval -81.8 to -6.5	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Week 97 to 108	-64.3 percentage change Interval -91.7 to -22.2	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Week 145 to 156	-69.4 percentage change Interval -96.1 to -24.1	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Week 205 to 216	-72.3 percentage change Interval -77.4 to -55.6	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Week 253 to 264	-55.6 percentage change Interval -70.0 to 91.7	—
Percent Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Convulsive Seizure Frequency in Participants With Dravet Syndrome Last 12 weeks	-40.0 percentage change Interval -77.8 to 6.7	—

PRIMARY outcome

Timeframe: Baseline; At last 12 weeks

Population: Safety Analysis Set. Only participants with available data are analyzed.

Status epilepticus is defined as any seizure lasting for 30 minutes or longer. The number of convulsive seizures greater than 30 minutes in duration and the number of non-convulsive seizures greater than 30 minutes in duration were collected weekly. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. mins = minutes. "Last 12 weeks" is equal to the last 12 weeks' data for each participant irrespective of time in study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Convulsive SE: Over the 4-week Baseline; Yes	14 participants	14 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Convulsive SE: Last 12 Weeks; No	277 participants	356 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Non-Convulsive SE: Last 12 Weeks; Yes	14 participants	11 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Non-Convulsive SE: Last 12 Weeks; No	276 participants	352 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Convulsive SE: Last 12 Weeks; Yes	13 participants	7 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Convulsive SE: Over the 4-week Baseline; No	277 participants	352 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Non-Convulsive SE: Over the 4-week Baseline; Yes	21 participants	17 participants
Number of Participants With Convulsive and Non-convulsive Seizures Greater Than 30 Minutes in Duration (Status Epilepticus) Non-Convulsive SE: Over the 4-week Baseline; No	270 participants	349 participants

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

The QOLCE is a parent-reported questionnaire that evaluates health-related QOL in children aged 2-18 years old. It contains 76 items with 16 subscales covering 7 domains (physical activities, social activities, cognition, emotional well-being, behavior, general health, and general QOL). All items in the questionnaire are rated on a 5-point or 6-point categorical scale. Based on the responses to the items in each domain, scores for 16 subscales are derived. Score range from 0 to 100. Higher score indicate highest level of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as the Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=169 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=118 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Quality of Life in Childhood Epilepsy (QOLCE) Scores	3.7 Scores on a scale Standard Deviation 14.61	6.0 Scores on a scale Standard Deviation 13.87

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: Safety Analysis Set. Only participants with available data were analyzed.

The QOLIE-31-P is a survey of health-related QOL for adults with epilepsy. It is comprised of 38 questions about health daily activities and evaluates how much distress the participant feels about problems and worries related to epilepsy. The questionnaire consists of 7 subscales (energy, mood, daily activities, cognition, medication effects, seizure worry, and overall QOL). Scores range from 0 to 100. Higher scores indicate better QOL. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study. The outcome was reported for Lennox-Gastaut Syndrome participants only.

Outcome measures

Measure	Dravet Syndrome n=38 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment QOL in Epilepsy Scores (QOLIE-31-P) in Participants With Lennox-Gastaut Syndrome	1.3 Scores on a scale Standard Deviation 16.33	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: Safety Analysis Set. Only those participants with available data were analyzed.

The Vineland-II is an individually administered instrument for assessing adaptive behaviors. It consists of 4 adaptive behavior domains (1 = low; 5 = high) and a maladaptive behavior domain (1 = clinically significant; 3 = average), and an overall Adaptive Behavior Composite Score. Standard scores (population mean = 100, SD = 15, range = 20 to 160) are produced for the domain and composite scores, and scaled scores (called v-scale scores, with a population mean = 15, SD = 3, range = 1 to 24) are produced for the subscale scores. Higher scores indicate better functioning.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Pre-randomization Baseline of the Core Study is defined as Baseline of the double-blind, placebo-controlled, clinical studies with GWP42003-P. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Motor Skills Domain Standard Score	-0.7 Scores on a scale Standard Deviation 9.62	-1.9 Scores on a scale Standard Deviation 10.23
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Communication: Receptive Subdomain v-Scale Score	-0.4 Scores on a scale Standard Deviation 2.12	-0.5 Scores on a scale Standard Deviation 2.76
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Communication: Expressive Subdomain v-Scale Score	-0.8 Scores on a scale Standard Deviation 1.65	-0.3 Scores on a scale Standard Deviation 2.20
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Communication: Written Subdomain v-Scale Score	-1.1 Scores on a scale Standard Deviation 1.80	-0.7 Scores on a scale Standard Deviation 1.80
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Communication Domain Standard Score	-3.2 Scores on a scale Standard Deviation 8.75	-1.6 Scores on a scale Standard Deviation 13.50
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Daily Living Skills: Personal Subdomain v-Scale Score	-1.0 Scores on a scale Standard Deviation 1.92	-0.8 Scores on a scale Standard Deviation 2.05
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Daily Living Skills: Domestic Subdomain v-Scale Score	-0.8 Scores on a scale Standard Deviation 2.04	-1.0 Scores on a scale Standard Deviation 1.32
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Daily Living Skills: Community Subdomain v-Scale Score	-0.9 Scores on a scale Standard Deviation 2.75	-0.8 Scores on a scale Standard Deviation 1.49
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Daily Living Skills Domain Standard Score	-5.0 Scores on a scale Standard Deviation 9.68	-3.9 Scores on a scale Standard Deviation 8.40
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Socialization: Interpersonal Relationships Subdomain v-Scale Score	-0.7 Scores on a scale Standard Deviation 1.66	-0.6 Scores on a scale Standard Deviation 2.17
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Socialization: Play and Leisure Time Subdomain v-Scale Score	-0.9 Scores on a scale Standard Deviation 2.29	-0.4 Scores on a scale Standard Deviation 2.22
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Socialization: Coping Skills Subdomain v-Scale Score	-0.7 Scores on a scale Standard Deviation 2.24	-0.5 Scores on a scale Standard Deviation 1.85
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Socialization Domain Standard Score	-3.3 Scores on a scale Standard Deviation 9.38	-3.4 Scores on a scale Standard Deviation 11.29
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Motor Skills: Gross Subdomain v-Scale Score	-0.2 Scores on a scale Standard Deviation 1.64	-0.3 Scores on a scale Standard Deviation 1.88
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Motor Skills: Fine Subdomain v-Scale Score	-0.3 Scores on a scale Standard Deviation 1.99	-0.4 Scores on a scale Standard Deviation 2.19
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Adaptive Behavior Composite Standard Score	-3.4 Scores on a scale Standard Deviation 8.09	-2.5 Scores on a scale Standard Deviation 10.07
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Maladaptive Behavior Index: Internalizing Subdomain v-Scale Score	-0.1 Scores on a scale Standard Deviation 2.28	-0.1 Scores on a scale Standard Deviation 2.64
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Maladaptive Behavior Index: Externalizing Subdomain v-Scale Score	-0.3 Scores on a scale Standard Deviation 2.22	-0.1 Scores on a scale Standard Deviation 2.12
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Vineland Adaptive Behavior Scale, Second Edition (Vineland-II) Scores Maladaptive Behavior Index v-Scale Score	-0.3 Scores on a scale Standard Deviation 1.92	-0.3 Scores on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Week 48, 104, 156, 208, and End of Treatment (up to Week 260 based on when the participant discontinued treatment)

Population: Safety Analysis Set

Inpatient hospitalizations due to epilepsy were recorded by the investigator. The timing of the "End of Treatment" varied per participant based on when the participant discontinued IMP.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit Week 48	5 Participants	9 Participants
Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit Week 104	4 Participants	9 Participants
Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit Week 156	3 Participants	0 Participants
Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit Week 208	0 Participants	0 Participants
Number of Participants With Inpatient Hospitalizations Due to Epilepsy Since the Previous Visit End of Treatment	16 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline; Week 49 to 60, Week 97 to 108, Week 145 to 156, Week 205 to 216, Week 253 to 264, and Last 12 Weeks

Population: Safety Analysis Set. Only participants with available data were analyzed.

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Week 49 to 60	108 Participants	169 Participants
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Week 97 to 108	73 Participants	148 Participants
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Week 145 to 156	48 Participants	128 Participants
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Week 205 to 216	7 Participants	12 Participants
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Week 253 to 264	2 Participants	—
Number of Treatment Responders With Greater Than or Equal to 50% Reduction in Total Seizures Last 12 Weeks	153 Participants	188 Participants

SECONDARY outcome

Timeframe: Up to Week 260

Population: Safety Analysis Set. Only participants with available data are analyzed.

The SGICSD and CGICSD are comprised of the following questions rated on a 3-point scale for each seizure type. The CGICSD score is used to assess the average duration of the participant's seizures (comparing their condition now to their condition before treatment) and the SGICSD score is used to assess the average duration of seizures (comparing condition now to condition before treatment). Scores range from 1 to 3 (1 = Decrease in average duration; 3 = Increase in average duration).

Outcome measures

Measure	Dravet Syndrome n=291 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Tonic-Clonic Seizures; End of Treatment · Increase in average duration	17 Participants	24 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Clonic Seizures; End of Treatment · Decrease in average duration	41 Participants	38 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Atonic Seizures; End of Treatment · Decrease in average duration	26 Participants	98 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Atonic Seizures; End of Treatment · Increase in average duration	6 Participants	10 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Myoclonic Seizures; End of Treatment · Increase in average duration	14 Participants	4 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Countable Partial Seizures; End of Treatment · Decrease in average duration	34 Participants	41 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Other Partial Seizures; End of Treatment · Decrease in average duration	25 Participants	29 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Absence Seizures; End of Treatment · Increase in average duration	9 Participants	3 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Tonic-Clonic Seizures; End of Treatment · Decrease in average duration	89 Participants	101 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Tonic Seizures; End of Treatment · Decrease in average duration	39 Participants	132 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Tonic Seizures; End of Treatment · Increase in average duration	8 Participants	18 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Clonic Seizures; End of Treatment · Increase in average duration	4 Participants	3 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Myoclonic Seizures; End of Treatment · Decrease in average duration	48 Participants	72 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Countable Partial Seizures; End of Treatment · Increase in average duration	8 Participants	5 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Other Partial Seizures; End of Treatment · Increase in average duration	6 Participants	0 Participants
Number of Participants With Changes in the Average Duration of Seizure Subtypes as Assessed by the Participant/Caregiver Global Impression of Change in Seizure Duration (S/CGICSD) Absence Seizures; End of Treatment · Decrease in average duration	42 Participants	83 Participants

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

D-KEFS Visual Scanning Completion Time Scale was used to measure visual attention and processing speed. The cognitive assessment battery items are age-specific, used to measure a variety of functions for both children and adults. The items were administered by an experienced psychometrician to a sub-group of sites that had the expertise to conduct the test. The raw score i.e., total time in seconds for completing the visual scanning trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=3 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Delis-Kaplan Executive Function System (D-KEFS) Visual Scanning Completion Time Scaled Score	0.00 Score on a scale Standard Deviation 0.00	-0.33 Score on a scale Standard Deviation 0.577

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

D-KEFS Number Sequencing Completion Time Scale was used to measure processing speed. The raw score i.e., total time in seconds for completing the number sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to convert into a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=2 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number Sequencing Completion Time Scaled Score	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

D-KEFS Letter Sequencing Completion Time Scaled was used to measure processing speed. The raw score i.e., total time in seconds for completing the letter sequencing trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=2 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Letter Sequencing Completion Time Scaled Score	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

D-KEFS Number-letter Switching Completion Time Scale was used to measure cognitive flexibility, task-set switching, and general executive functioning. The raw score i.e., total time in seconds for completing the number-letter switching trial was measured in the range of 0-240; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in cognitive function. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=2 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Number-letter Switching Completion Time Scaled Score	0.00 Score on a scale Standard Deviation 0.00	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

D-KEFS Motor Speed Completion Time Scale was used to measure motor speed. The raw score i.e., total time in seconds for completing the motor speed trial was measured in the range of 0-150; higher scores indicated worse functioning. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better motor speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in motor speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=3 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in D-KEFS Motor Speed Completion Time Scaled Score	0.00 Score on a scale Standard Deviation 0.00	-1.33 Score on a scale Standard Deviation 2.309

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Purdue Pegboard test was used to measure fine motor dexterity of both hands. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=17 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=11 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Both Hands Z Score)	1.26 Z Score Standard Deviation 3.272	9.55 Z Score Standard Deviation 21.070

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Purdue Pegboard test was used to measure fine motor dexterity of the dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=17 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=12 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Dominant Hand Z Score)	1.16 Z Score Standard Deviation 3.192	9.23 Z Score Standard Deviation 18.083

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Purdue Pegboard test was used to measure fine motor dexterity of the non dominant hand. The raw score was calculated as the total number of pegs in 30 seconds; higher scores indicated higher level of motor dexterity. The raw score was converted to a Z-score ranging from 0-19; higher scores indicate a higher level of motor dexterity. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as Z-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in motor dexterity. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=17 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=12 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Purdue Pegboard Fine Motor Speed (Non Dominant Hand Z Score)	1.31 Z Score Standard Deviation 3.329	10.21 Z Score Standard Deviation 21.852

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS Coding Scale was used to measure processing speed. The raw score i.e., sum of correct substitutions was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=2 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Adult Intelligence Scale (WAIS) Coding Scaled Score	—	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score Week 48	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.25 Score on a scale Standard Deviation 0.50
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score Baseline	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.0 Score on a scale Standard Deviation 0.0
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Backward Scaled Score End of Treatment	—	-0.14 Score on a scale Standard Deviation 0.378

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 0-16. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score Week 48	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	-0.25 Score on a scale Standard Deviation 1.258
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score Baseline	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.13 Score on a scale Standard Deviation 1.808
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Digit Span Forward Scaled Score End of Treatment	—	0.14 Score on a scale Standard Deviation 2.268

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score Baseline	0.00 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.00 Score on a scale Standard Deviation 0.00
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score Week 48	0.00 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.00 Score on a scale Standard Deviation 0.00
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Backward Scaled Score End of Treatment	—	0.00 Score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured in the range of 2-8. The raw score was normed with a referenced score to calculate a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score Baseline	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.13 Score on a scale Standard Deviation 1.642
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score Week 48	0.0 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	0.25 Score on a scale Standard Deviation 1.258
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WAIS Longest Digit Span Forward Scaled Score End of Treatment	—	-0.14 Score on a scale Standard Deviation 1.574

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WAIS-II Vocabulary T Score was used to estimate general intellectual ability based on fund of information and verbal intelligence. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=4 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=6 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Abbreviated Scale of Intelligence (WASI)-II Vocabulary T Score	0.00 T Score Standard Deviation 0.00	-4.00 T Score Standard Deviation 12.247

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WASI-II Matrix Reasoning T Score was used to estimate general intellectual ability based abstract reasoning. The raw score i.e., the sum of correct responses was converted to a T-score ranging from 20-80 using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=4 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=7 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WASI-II Matrix Reasoning T Score	-1.50 T Score Standard Deviation 3.000	-3.29 T Score Standard Deviation 5.376

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WISC Coding Scale was used to measure processing speed in children aged 6-16 years 11 months, with scores ranging from 0 to 119. Higher scores indicate better processing speed. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in processing speed. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=5 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Intelligence Scale for Children (WISC) Coding Scaled Score	-0.40 Score on a scale Standard Deviation 1.817	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WISC Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=6 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Backward Scaled Score	0.00 Score on a scale Standard Deviation 0.632	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WISC Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 0-18; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=7 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Digit Span Forward Scaled Score	0.57 Score on a scale Standard Deviation 0.787	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WISC Longest Digit Span Backward Scale was used to measure working memory. The raw score i.e., sum of correct trials was measured on a scale of 2-8; higher scores indicated better working memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in working memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=6 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Backward Scaled Score	0.00 Score on a scale Standard Deviation 1.265	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WISC Longest Digit Span Forward Scale was used to measure auditory memory. The raw score i.e., sum of correct trials was measured on a scale of 2-10; higher scores indicated better auditory memory. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in auditory memory. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=6 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WISC Longest Digit Span Forward Scaled Score	0.17 Score on a scale Standard Deviation 0.408	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WPPSI-IV Bug Search T Score was used to measure processing speed and complex attention. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of attention. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in attention. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Preschool & Primary Scale of Intelligence (WPPSI)-IV Bug Search T Score Baseline	0.0 T Score Standard Deviation 0.0	—
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Wechsler Preschool & Primary Scale of Intelligence (WPPSI)-IV Bug Search T Score Week 48	0.0 T Score Standard Deviation NA Standard deviation was not calculated for a single participant.	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WPPSI-IV Receptive Vocabulary T Score was used to measure fund of information. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of intelligence. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in intelligence. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=1 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Receptive Vocabulary T Score	—	-1.00 T Score Standard Deviation NA Standard deviation was not calculated for a single participant.

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

WPPSI-IV Matrix Reasoning T Score was used to measure abstract reasoning. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 20-80; T-scores are standard scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of abstract reasoning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in abstract reasoning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=315 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score Baseline	0.75 T Score Standard Deviation 6.994	-19.0 T Score Standard Deviation NA Standard deviation was not calculated for a single participant.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in WPPSI-IV Matrix Reasoning T Score Week 48	-0.75 T Score Standard Deviation 6.994	—

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Expressive One-Word Picture Vocabulary Test-4th edition was used to test vocabulary. The raw score i.e., the sum of correct responses was measured on a scale of 1-19 and converted to a T-score ranging from 0-83; T-scores are standard scores with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher level of language performance. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as as T-score (i.e., score on a scale). Negative values indicate worsening and positive values indicate improvement in language performance. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=2 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Expressive One-Word Picture Vocabulary Test (EOWPVT) Scaled Score	-31.00 T score Standard Deviation 56.569	-31.00 T score Standard Deviation 53.740

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scale was used to measure verbal fluency. The raw score i.e., the sum of correct responses was converted to a scaled score (i.e., score on a scale) ranging from 1-19; higher scores indicate a higher level of verbal fluency. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in verbal fluency. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=2 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=1 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in a Developmental NEuroPSYchological Assessment (NEPSY)-2 Word Generation Scaled Score	-1.00 Score on a scale Standard Deviation 1.414	3.39 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.

SECONDARY outcome

Timeframe: Baseline; up to Week 260

Population: ITT Analysis Set. Only participants with available data were analyzed.

Visual Perception Standard scale was used to measure visual motor functioning. The raw score i.e., the sum of the correct responses was measured on a 6-standard score range. Score range of 70-79 indicated "low," 80-89 indicated "below average," 90-109 indicated "average," 110-119 indicated "above average," 120-129 indicated "high," and >129 indicated "very high" visual motor functioning. Change from the pre-randomization Baseline of the core study to the End of Treatment are reported as score on a scale. Negative values indicate worsening and positive values indicate improvement in visual motor functioning. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data at pre-randomization of the Core Study.

Outcome measures

Measure	Dravet Syndrome n=1 Participants Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=3 Participants Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Mean Change From the Pre-randomization Baseline of the Core Study to the End of Treatment in Visual Perception Standard Scaled Score	0.00 Score on a scale Standard Deviation NA Standard deviation was not calculated for a single participant.	2.67 Score on a scale Standard Deviation 7.767

Adverse Events

Dravet Syndrome

Serious events: 133 serious events

Other events: 292 other events

Deaths: 6 deaths

Lennox-Gastaut Syndrome

Serious events: 157 serious events

Other events: 338 other events

Deaths: 12 deaths

Serious adverse events

Measure	Dravet Syndrome n=315 participants at risk Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 participants at risk Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Blood and lymphatic system disorders Neutropenia	0.95% 3/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Blood and lymphatic system disorders Thrombocytopenia	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Cardiac disorders Cardiac arrest	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Cardiac disorders Cardio-respiratory arrest	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Cardiac disorders Tachycardia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Congenital, familial and genetic disorders Rett's disorder	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Eye disorders Blindness transient	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Eye disorders Eye oedema	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Abdominal distension	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Abdominal pain	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Colitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Constipation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Diarrhoea	1.6% 5/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.4% 5/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Faecaloma	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Haematemesis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Haematochezia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Ileus	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.1% 4/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Ileus paralytic	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Intestinal obstruction	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Intestinal perforation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Nausea	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Oesophagitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Proctalgia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Tooth loss	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Vomiting	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	3.6% 13/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Asthenia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Chest pain	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Device dislocation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Device malfunction	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Drowning	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Drug withdrawal syndrome	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Effusion	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Fatigue	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Generalised oedema	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Hypothermia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Malaise	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Pain	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Pyrexia	5.4% 17/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	3.0% 11/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Sudden unexplained death in epilepsy	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.1% 4/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Hepatobiliary disorders Cholecystitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Hepatobiliary disorders Hepatitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Hepatobiliary disorders Hepatitis acute	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Hepatobiliary disorders Hepatotoxicity	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Abdominal wall abscess	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Appendicitis	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Appendicitis perforated	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Atypical pneumonia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Bacteraemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Bronchitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Catheter site abscess	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Cellulitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Cellulitis staphylococcal	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Clostridium difficile infection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Colon gangrene	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Corona virus infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Croup infectious	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Cystitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Device related infection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Empyema	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Enterococcal infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Enterovirus infection	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Epstein-Barr virus infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Escherichia infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Gastroenteritis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Gastroenteritis viral	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Infected bites	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Infection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Infectious mononucleosis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Infective myositis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Influenza	2.2% 7/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Klebsiella infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Laryngitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Lobar pneumonia	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.4% 5/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Lower respiratory tract infection	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Meningitis viral	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Metapneumovirus infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Myelitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Oral candidiasis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Otitis externa	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Otitis media	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Otitis media acute	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Parainfluenzae virus infection	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Peritonitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pertussis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pharyngitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pharyngitis streptococcal	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia	6.3% 20/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.1% 26/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia bacterial	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia influenzal	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia pseudomonal	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia respiratory syncytial viral	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia staphylococcal	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia viral	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pseudomonas infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pyelonephritis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pyelonephritis acute	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Rectal abscess	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Respiratory syncytial virus infection	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Respiratory tract infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Respiratory tract infection viral	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Rhinovirus infection	0.95% 3/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Sepsis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Septic shock	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Sinusitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Staphylococcal infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Superinfection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Superinfection bacterial	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Tracheitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Tracheobronchitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Upper respiratory tract infection	0.95% 3/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Urinary tract infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	2.5% 9/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Viral infection	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Viral pharyngitis	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Viral upper respiratory tract infection	0.95% 3/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations West Nile viral infection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Wound infection	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Concussion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Contusion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Ear injury	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Extradural haematoma	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Fall	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Feeding tube complication	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Fracture	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Hand fracture	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Head injury	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Injury	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Multiple fractures	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Near drowning	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Skull fracture	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Tooth avulsion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Toxicity to various agents	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Alanine aminotransferase increased	2.2% 7/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.9% 7/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Ammonia increased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Anticonvulsant drug level increased	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Aspartate aminotransferase increased	3.2% 10/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Blood alkaline phosphatase increased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Blood lactate dehydrogenase increased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Body temperature fluctuation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Eosinophil count increased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Gamma-glutamyltransferase increased	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Gastrointestinal stoma output increased	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Hepatic enzyme increased	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations International normalised ratio increased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Lipase increased	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Liver function test abnormal	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Norovirus test positive	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Oxygen consumption increased	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Oxygen saturation decreased	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Platelet count decreased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Transaminases abnormal	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Transaminases increased	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.4% 5/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Weight decreased	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.1% 4/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Dehydration	1.9% 6/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.4% 5/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Enteral feeding intolerance	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hypokalaemia	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hyponatraemia	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Hypophagia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Metabolic disorder	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Altered state of consciousness	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Ataxia	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Balance disorder	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Cerebral atrophy	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Convulsion	10.8% 34/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	12.0% 44/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Depressed level of consciousness	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Dyskinesia	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Encephalopathy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Epilepsy	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Generalised tonic-clonic seizure	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Hemiparesis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Lethargy	0.95% 3/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Metabolic encephalopathy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Movement disorder	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Myoclonic epilepsy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Myoclonus	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Neuromyopathy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Partial seizures	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Postictal state	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Sedation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Seizure cluster	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Somnolence	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Status epilepticus	14.9% 47/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	11.5% 42/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Abnormal behaviour	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Aggression	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.55% 2/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Agitation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Anxiety	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Confusional state	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Hallucinations, mixed	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Irritability	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Mental status changes	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Self injurious behaviour	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Sleep disorder	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Haematuria	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Nephrocalcinosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Renal cyst	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Renal failure acute	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.4% 5/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Urinary incontinence	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Renal and urinary disorders Urinary retention	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.82% 3/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Reproductive system and breast disorders Testicular torsion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	2.7% 10/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Choking	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	2.5% 9/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.3% 4/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	4.4% 16/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.63% 2/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	2.2% 8/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Stridor	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.32% 1/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.00% 0/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Social circumstances Child abuse	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Surgical and medical procedures Foot operation	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Surgical and medical procedures Gastrostomy	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	0.27% 1/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Vascular disorders Hypotension	0.00% 0/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.1% 4/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.

Other adverse events

Measure	Dravet Syndrome n=315 participants at risk Participants with Dravet Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], and GWEP1424 \[NCT02224703\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.	Lennox-Gastaut Syndrome n=366 participants at risk Participants with Lennox-Gastaut Syndrome who completed double-blind, placebo-controlled, clinical studies of GWP42003-P (Core Studies: GWEP1414 \[NCT02224560\] and GWEP1423 \[NCT02224690\]) were titrated up to 10 to 20 milligrams per kilogram per day (mg/kg/day) GWP42003-P using a recommended titration schedule during the Titration Period. Participants continued at this dose during the Maintenance Period. The maximum dose participants could receive was 30 mg/kg/day.
Gastrointestinal disorders Constipation	6.3% 20/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	11.2% 41/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Diarrhoea	42.2% 133/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	37.7% 138/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Nausea	5.1% 16/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	8.2% 30/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Gastrointestinal disorders Vomiting	20.0% 63/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	27.0% 99/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Fatigue	12.1% 38/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	10.4% 38/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Bronchitis	4.4% 14/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	6.3% 23/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
General disorders Pyrexia	37.1% 117/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	33.6% 123/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Ear infection	11.1% 35/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	13.7% 50/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Gastroenteritis	5.1% 16/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	1.6% 6/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Gastroenteritis viral	3.5% 11/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.9% 29/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Influenza	9.8% 31/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	11.5% 42/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Nasopharyngitis	24.8% 78/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	15.8% 58/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Otitis media	6.7% 21/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	5.7% 21/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pharyngitis streptococcal	7.6% 24/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.1% 26/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Sinusitis	12.1% 38/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	13.1% 48/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Pneumonia	7.0% 22/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	8.5% 31/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Upper respiratory tract infection	24.4% 77/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	27.9% 102/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Urinary tract infection	5.7% 18/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	12.8% 47/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Infections and infestations Viral upper respiratory tract infection	2.9% 9/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	5.2% 19/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Contusion	4.8% 15/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	6.6% 24/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Fall	6.3% 20/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	5.5% 20/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Injury, poisoning and procedural complications Laceration	2.5% 8/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	9.6% 35/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Alanine aminotransferase increased	9.8% 31/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	6.3% 23/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Aspartate aminotransferase increased	9.5% 30/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	3.6% 13/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Gamma-glutamyltransferase increased	9.2% 29/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	4.9% 18/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Investigations Weight decreased	6.3% 20/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	15.8% 58/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Metabolism and nutrition disorders Decreased appetite	31.4% 99/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	25.1% 92/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Convulsion	19.0% 60/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	32.8% 120/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Drooling	3.5% 11/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	5.7% 21/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Headache	5.7% 18/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.1% 26/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Lethargy	6.0% 19/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	8.7% 32/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Sedation	5.1% 16/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.4% 27/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Nervous system disorders Somnolence	27.3% 86/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	29.0% 106/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Abnormal behaviour	10.2% 32/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	6.0% 22/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Aggression	6.0% 19/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.9% 29/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Insomnia	5.1% 16/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	10.9% 40/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Psychiatric disorders Irritability	8.3% 26/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	7.7% 28/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 42/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	17.2% 63/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.1% 13/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	12.6% 46/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.0% 19/315 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.	5.2% 19/366 • Up to Week 260 Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that started, worsened in severity or seriousness, following the first dose of investigational medicinal product in this study, whether or not considered related to the participant's participation in the research, are reported. Any AEs that continued from the Core Study were only classified as treatment emergent if they worsened in this study.

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