Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy (NCT NCT03739840)

NCT ID: NCT03739840

Last Updated: 2022-12-21

Results Overview

During the study, participants kept diaries to record daily seizure activity. Seizure frequency refers to 28-day adjusted frequency. Seizure frequency was based on investigator assessment of participants' reports of daily seizure type and frequency. Observable focal-onset seizures refer to Type IA1, IB, and IC (ILAE Classification of Epileptic Seizures, 1981). Based on ANCOVA on change in log-transformed seizure frequency from Baseline, with treatment group as the main factor, Baseline log-transformed seizure frequency as a continuous covariate, Baseline SV2A use (Yes or No) and Region (Europe, non-Europe) as categorical factors.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 232 participants
• Primary outcome timeframe: From Baseline over the 12 Week Maintenance Period (up to Week 16)
• Results posted on: 2022-12-21

Participant Flow

The study started to enroll participants in March 2019 and concluded in September 2020.

The study included: a 4-week Baseline Period, a 16-week Treatment Period, a 4-week Taper Period (for participants who discontinued or choose not to enroll in the open-label extension study) and a Safety Follow-up Period. Participants continuing to the OLE study had a 3-week Conversion Period. The Participant Flow refers to the Randomized Set.

Participant milestones

Measure	Placebo Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19.	Padsevonil 100 mg BID Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 200 mg BID Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 400 mg BID Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19
Treatment Period: Wk0-16 STARTED	56	60	57	59
Treatment Period: Wk0-16 Completed Titration and Stabilization	54	58	51	54
Treatment Period: Wk0-16 Completed Maintenance Period	46	44	44	36
Treatment Period: Wk0-16 COMPLETED	46	44	44	36
Treatment Period: Wk0-16 NOT COMPLETED	10	16	13	23
Post-Treatment Period: Wk16-23 STARTED	46	44	44	36
Post-Treatment Period: Wk16-23 Started Conversion Period	33	31	29	28
Post-Treatment Period: Wk16-23 Completed Conversion Period	33	31	29	28
Post-Treatment Period: Wk16-23 Started Taper and Safety Follow-up	19	18	21	13
Post-Treatment Period: Wk16-23 Completed Taper and Safety Follow-up	15	16	18	12
Post-Treatment Period: Wk16-23 Enrolled in EP0093	27	26	23	23
Post-Treatment Period: Wk16-23 COMPLETED	42	42	41	35
Post-Treatment Period: Wk16-23 NOT COMPLETED	4	2	3	1

Reasons for withdrawal

Measure	Placebo Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19.	Padsevonil 100 mg BID Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 200 mg BID Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 400 mg BID Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19
Treatment Period: Wk0-16 Adverse Event	2	6	6	12
Treatment Period: Wk0-16 Lack of Efficacy	0	1	0	3
Treatment Period: Wk0-16 Protocol Violation	0	0	1	0
Treatment Period: Wk0-16 Consent Withdrawn	1	3	1	1
Treatment Period: Wk0-16 Program Termination	3	0	1	1
Treatment Period: Wk0-16 Sponsor Closed Study- Subject Was Discontinued	1	0	0	0
Treatment Period: Wk0-16 Sponsors Decision	3	2	1	3
Treatment Period: Wk0-16 Promotor Decision	0	1	0	0
Treatment Period: Wk0-16 Per Sponsor Study Closed	0	1	0	0
Treatment Period: Wk0-16 Premature Program Termination	0	1	0	0
Treatment Period: Wk0-16 Trial Closed By Sponsor	0	1	0	0
Treatment Period: Wk0-16 Study Early Closure	0	0	1	0
Treatment Period: Wk0-16 Premature Study Termination By Sponsor	0	0	1	0
Treatment Period: Wk0-16 Premature Closure Of The Study	0	0	1	0
Treatment Period: Wk0-16 Study Has Been Cancelled By The Sponsor	0	0	0	1
Treatment Period: Wk0-16 Due To Sponsor Instruction	0	0	0	1
Treatment Period: Wk0-16 Trial Was Closed By Sponsor	0	0	0	1
Post-Treatment Period: Wk16-23 Adverse Event	3	0	0	0
Post-Treatment Period: Wk16-23 Consent Withdrawn	0	0	0	1
Post-Treatment Period: Wk16-23 Sponsor Decision To Terminate The Study	1	0	0	0
Post-Treatment Period: Wk16-23 Sponsor's Decision	0	1	0	0
Post-Treatment Period: Wk16-23 Sponsor Closed Study- Subject Was Discontinued	0	1	0	0
Post-Treatment Period: Wk16-23 Sponsor Decision + Subject Refusal	0	0	1	0
Post-Treatment Period: Wk16-23 Early Study Closure	0	0	1	0
Post-Treatment Period: Wk16-23 Trial Closed By Sponsor Decision	0	0	1	0

Baseline Characteristics

A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

Baseline characteristics by cohort

Measure	Placebo n=56 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, twice daily (bid) up to Week 19.	Padsevonil 100 mg BID n=60 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 200 mg BID n=57 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19.	Padsevonil 400 mg BID n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19	Total Title n=232 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	57 Participants n=7 Participants	48 Participants n=5 Participants	56 Participants n=4 Participants	213 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Age, Continuous	41.9 years STANDARD_DEVIATION 13.6 • n=5 Participants	40.7 years STANDARD_DEVIATION 13.0 • n=7 Participants	39.5 years STANDARD_DEVIATION 14.3 • n=5 Participants	39.7 years STANDARD_DEVIATION 13.6 • n=4 Participants	40.4 years STANDARD_DEVIATION 13.6 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	29 Participants n=5 Participants	34 Participants n=4 Participants	131 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants	25 Participants n=4 Participants	101 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	24 Participants n=21 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	49 Participants n=5 Participants	50 Participants n=7 Participants	49 Participants n=5 Participants	51 Participants n=4 Participants	199 Participants n=21 Participants
Race/Ethnicity, Customized Other/mixed	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline over the 12 Week Maintenance Period (up to Week 16)

Population: The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.

During the study, participants kept diaries to record daily seizure activity. Seizure frequency refers to 28-day adjusted frequency. Seizure frequency was based on investigator assessment of participants' reports of daily seizure type and frequency. Observable focal-onset seizures refer to Type IA1, IB, and IC (ILAE Classification of Epileptic Seizures, 1981). Based on ANCOVA on change in log-transformed seizure frequency from Baseline, with treatment group as the main factor, Baseline log-transformed seizure frequency as a continuous covariate, Baseline SV2A use (Yes or No) and Region (Europe, non-Europe) as categorical factors.

Outcome measures

Measure	Placebo (FAS) n=54 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period	-0.41 log e seizures per 28 days Interval -0.6133 to -0.2025	-0.35 log e seizures per 28 days Interval -0.54906 to -0.15705	-0.47 log e seizures per 28 days Interval -0.67559 to -0.27382	-0.47 log e seizures per 28 days Interval -0.67267 to -0.27361

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to Week 23)

Population: The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.

Outcome measures

Measure	Placebo (FAS) n=55 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=60 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=57 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	69.1 percentage of participants	83.3 percentage of participants	78.9 percentage of participants	84.7 percentage of participants

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to Week 23)

Population: The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.

Outcome measures

Measure	Placebo (FAS) n=55 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=60 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=57 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal	7.3 percentage of participants	10.0 percentage of participants	10.5 percentage of participants	20.3 percentage of participants

PRIMARY outcome

Timeframe: From Baseline until Safety Follow-Up (up to Week 23)

Population: The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP.

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is as infection that requires treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.

Outcome measures

Measure	Placebo (FAS) n=55 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=60 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=57 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)	9.1 percentage of participants	3.3 percentage of participants	1.8 percentage of participants	10.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline over the 12 Week Maintenance Period (up to Week 16)

Population: The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.

The 75 % responder rate, where a responder was a participant experiencing a ≥75 % reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period.

Outcome measures

Measure	Placebo (FAS) n=54 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
75% Responder Rate From Baseline Over the 12-week Maintenance Period	13.0 percentage of participants	15.3 percentage of participants	12.5 percentage of participants	14.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline over the 12 Week Maintenance Period (up to Week 16)

Population: The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.

The 50% responder rate, where a responder was a participant experiencing a ≥50% reduction in observable focal-onset seizure frequency from Baseline, over the 12-week Maintenance Period.

Outcome measures

Measure	Placebo (FAS) n=54 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
50% Responder Rate From Baseline Over the 12-week Maintenance Period	27.8 percentage of participants	35.6 percentage of participants	33.9 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: From Baseline over the 12 Week Maintenance Period (up to Week 16)

Population: The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. Here, number of participants were included who were evaluable for the assessment.

During the study, participants kept diaries to record daily seizure activity. The percentage of participants who experienced a 50 % or greater reduction in seizure frequency per 28 days relative to Baseline (responders) were assessed.

Outcome measures

Measure	Placebo (FAS) n=54 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 100 mg BID (FAS) n=59 Participants Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 200 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.	Padsevonil 400 mg BID (FAS) n=56 Participants Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the FAS.
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance Period	22.34 percent change Standard Deviation 44.56	11.72 percent change Standard Deviation 81.52	30.29 percent change Standard Deviation 39.58	22.41 percent change Standard Deviation 62.80

Adverse Events

Placebo Treatment Period (SS)

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Padsevonil 100 mg BID Treatment Period (SS)

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Padsevonil 200 mg BID Treatment Period (SS)

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Padsevonil 400 mg BID Treatment Period (SS)

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo Conversion Period (SS)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Padsevonil 100 mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Padsevonil 200 mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Padsevonil 400 mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Taper and SFU Period (SS)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Padsevonil 100 mg BID Taper and SFU Period (SS)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Padsevonil 200 mg BID Taper and SFU Period (SS)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Padsevonil 400 mg BID Taper and SFU Period (SS)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Treatment Period (SS) n=55 participants at risk Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Treatment Period (SS) n=60 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Padsevonil 200 mg BID Treatment Period (SS) n=57 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Padsevonil 400 mg BID Treatment Period (SS) n=59 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Placebo Conversion Period (SS) n=33 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the open-label extension (OLE) study at the end of the 12-Week Maintenance Period. Participants initially randomized to placebo progressively received padsevonil in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Conversion Period (SS) n=31 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 100 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Padsevonil 200 mg BID Conversion Period (SS) n=29 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 200 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Padsevonil 400 mg BID Conversion Period (SS) n=28 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 400 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Placebo Taper and SFU Period (SS) n=27 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to placebo group received 5-6 placebo tablets to maintain the blinding and have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Taper and SFU Period (SS) n=30 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 100 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.	Padsevonil 200 mg BID Taper and SFU Period (SS) n=31 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 200 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.	Padsevonil 400 mg BID Taper and SFU Period (SS) n=32 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 400 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Skin laceration	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Subdural haematoma	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Contusion	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Epilepsy	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.8% 1/57 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Focal dyscognitive seizures	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Seizure	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.3% 1/30 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Status epilepticus	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.1% 1/32 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Aggression	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Emotional disorder	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.7% 1/27 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Suicidal ideation	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.7% 1/27 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Surgical and medical procedures Abortion induced	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.3% 1/30 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.

Other adverse events

Measure	Placebo Treatment Period (SS) n=55 participants at risk Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding, bid up to Week 19. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Treatment Period (SS) n=60 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 100 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Padsevonil 200 mg BID Treatment Period (SS) n=57 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 200 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Padsevonil 400 mg BID Treatment Period (SS) n=59 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 400 mg and placebo (as appropriate) to maintain the blinding, bid up to Week 19. Participants formed the SS.	Placebo Conversion Period (SS) n=33 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the open-label extension (OLE) study at the end of the 12-Week Maintenance Period. Participants initially randomized to placebo progressively received padsevonil in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Conversion Period (SS) n=31 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 100 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Padsevonil 200 mg BID Conversion Period (SS) n=29 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 200 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Padsevonil 400 mg BID Conversion Period (SS) n=28 participants at risk A 3-Week Conversion Period was required for study participants who chose to enroll in the OLE study at the end of the 12-Week Maintenance Period. The dose for participants initially randomized to padsevonil 400 mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400 mg/day for the OLE. Participants formed the SS.	Placebo Taper and SFU Period (SS) n=27 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to placebo group received 5-6 placebo tablets to maintain the blinding and have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the Safety Set (SS).	Padsevonil 100 mg BID Taper and SFU Period (SS) n=30 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 100 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.	Padsevonil 200 mg BID Taper and SFU Period (SS) n=31 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 200 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.	Padsevonil 400 mg BID Taper and SFU Period (SS) n=32 participants at risk A 4-Week Taper Period was required for participants who chose not to enroll in the OLE study or who discontinued prior to the end of the 12-Week Maintenance Period. Participants initially randomized to padsevonil 400 mg bid have been gradually tapered off the IMP over a 3-week period followed by 1-week drug-free period. Afterwards, participants had a Safety Follow-Up visit 30 days after the last IMP intake. Participants formed the SS.
Gastrointestinal disorders Nausea	5.5% 3/55 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Gastrointestinal disorders Diarrhoea	5.5% 3/55 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 2/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
General disorders Fatigue	7.3% 4/55 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	8.3% 5/60 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	12.3% 7/57 • Number of events 7 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	23.7% 14/59 • Number of events 15 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
General disorders Asthenia	3.6% 2/55 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	10.0% 6/60 • Number of events 6 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 2/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.2% 1/31 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
General disorders Gait disturbance	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.3% 2/60 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.5% 2/57 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.8% 4/59 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Infections and infestations Nasopharyngitis	7.3% 4/55 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	7.0% 4/57 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Fall	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 2/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 1/29 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.7% 1/27 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.2% 1/31 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.1% 1/32 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Injury, poisoning and procedural complications Contusion	5.5% 3/55 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.5% 2/57 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 1/29 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.3% 1/30 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Metabolism and nutrition disorders Decreased appetite	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/59 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Somnolence	3.6% 2/55 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	16.7% 10/60 • Number of events 11 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	33.3% 19/57 • Number of events 22 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	33.9% 20/59 • Number of events 23 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.3% 1/30 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Dizziness	7.3% 4/55 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	23.3% 14/60 • Number of events 14 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	17.5% 10/57 • Number of events 13 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	30.5% 18/59 • Number of events 19 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.7% 1/27 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Headache	14.5% 8/55 • Number of events 13 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	16.7% 10/60 • Number of events 22 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	15.8% 9/57 • Number of events 16 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	8.5% 5/59 • Number of events 8 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	13.3% 4/30 • Number of events 12 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.5% 2/31 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.1% 1/32 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Memory impairment	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	10.2% 6/59 • Number of events 6 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Tremor	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.0% 3/60 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.8% 4/59 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.6% 1/28 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Disturbance in attention	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	8.8% 5/57 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 2/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Balance disorder	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.4% 2/59 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.2% 1/31 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Dysarthria	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	8.5% 5/59 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Nervous system disorders Seizure	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	7.0% 4/57 • Number of events 5 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Insomnia	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	8.8% 5/57 • Number of events 6 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.8% 4/59 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Irritability	5.5% 3/55 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.7% 4/60 • Number of events 4 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.3% 3/57 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.1% 3/59 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	3.0% 1/33 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Psychiatric disorders Anxiety	1.8% 1/55 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/60 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.8% 1/57 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	5.1% 3/59 • Number of events 3 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/33 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.
Vascular disorders Hypotension	0.00% 0/55 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	1.7% 1/60 • Number of events 1 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/57 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/59 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	6.1% 2/33 • Number of events 2 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/29 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/28 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/27 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/30 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/31 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.	0.00% 0/32 • TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23) TEAEs counts are for the number of study participants who entered the respective study period regardless of whether or not they completed the previous period. This is the reason for the difference in number of participants in Taper and SFU period in adverse events section and participant flow.

Additional Information

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Email: UCBCares@ucb.com

Results disclosure agreements

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

Restriction type: GT60