Trial Outcomes & Findings for Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy (NCT NCT03373383)

Last Updated: 2023-12-19

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, 28-day adjusted 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

COMPLETED

Study phase

PHASE2

Target enrollment

411 participants

Primary outcome timeframe

From Baseline over the 12 Week Maintenance Period

Results posted on

2023-12-19

Participant Flow

The study started to enroll patients in February 2018 and concluded in January 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. Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19.	Padsevonil 50mg BID Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19	Padsevonil 100mg 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 200mg 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 400mg 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	83	81	83	82	82
Treatment Period: Wk0-16 Completed Titration and Stabilization	78	72	71	68	65
Treatment Period: Wk0-16 Completed Maintenance Period	70	66	68	61	58
Treatment Period: Wk0-16 Had Taper and Safety Follow-up	6	11	8	18	21
Treatment Period: Wk0-16 COMPLETED	70	66	68	61	58
Treatment Period: Wk0-16 NOT COMPLETED	13	15	15	21	24
Post-Treatment Period: Wk16-23 STARTED	70	66	68	61	58
Post-Treatment Period: Wk16-23 Started Conversion Period	69	64	66	55	57
Post-Treatment Period: Wk16-23 Completed Conversion Period	68	64	66	55	57
Post-Treatment Period: Wk16-23 Had Taper and Safety Follow-up	3	3	3	6	1
Post-Treatment Period: Wk16-23 Enrolled in EP0093	67	63	65	55	57
Post-Treatment Period: Wk16-23 COMPLETED	69	66	68	61	58
Post-Treatment Period: Wk16-23 NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19.	Padsevonil 50mg BID Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19	Padsevonil 100mg 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 200mg 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 400mg 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	7	6	11	15	21
Treatment Period: Wk0-16 Lack of Efficacy	2	1	0	0	0
Treatment Period: Wk0-16 Protocol Violation	0	4	2	1	0
Treatment Period: Wk0-16 Lost to Follow-up	2	0	0	0	0
Treatment Period: Wk0-16 Withdrawal by Subject	2	3	2	3	3
Treatment Period: Wk0-16 As advised by the sponsor	0	1	0	0	0
Treatment Period: Wk0-16 By opinion of investigator	0	0	0	1	0
Treatment Period: Wk0-16 Sponsor decision	0	0	0	1	0
Post-Treatment Period: Wk16-23 Participant decided not to roll over	1	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=83 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19.	Padsevonil 50mg BID n=81 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 milligrams (mg) and placebo (as appropriate) to maintain the blinding, twice daily (bid) up to week 19	Padsevonil 100mg BID n=83 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 200mg BID n=82 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 400mg BID n=82 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=411 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants	76 Participants n=7 Participants	80 Participants n=5 Participants	79 Participants n=4 Participants	80 Participants n=21 Participants	397 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=8 Participants
Age, Continuous	40.0 years STANDARD_DEVIATION 12.9 • n=5 Participants	42.5 years STANDARD_DEVIATION 11.6 • n=7 Participants	36.9 years STANDARD_DEVIATION 13.1 • n=5 Participants	40.9 years STANDARD_DEVIATION 12.0 • n=4 Participants	38.8 years STANDARD_DEVIATION 12.1 • n=21 Participants	39.8 years STANDARD_DEVIATION 12.4 • n=8 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants	51 Participants n=4 Participants	43 Participants n=21 Participants	235 Participants n=8 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	31 Participants n=4 Participants	39 Participants n=21 Participants	176 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	33 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized White	69 Participants n=5 Participants	69 Participants n=7 Participants	73 Participants n=5 Participants	69 Participants n=4 Participants	71 Participants n=21 Participants	351 Participants n=8 Participants
Race/Ethnicity, Customized Other/mixed	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: From Baseline over the 12 Week Maintenance Period

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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=81 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=80 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=82 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 200mg BID (FAS) n=81 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 400mg BID (FAS) n=81 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	-0.27585 loge seizures per 28 days Interval -0.44311 to -0.10858	-0.46424 loge seizures per 28 days Interval -0.63276 to -0.29573	-0.48804 loge seizures per 28 days Interval -0.65436 to -0.32172	-0.48960 loge seizures per 28 days Interval -0.65734 to -0.32187	-0.40831 loge seizures per 28 days Interval -0.57485 to -0.24177

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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=83 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=81 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=83 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 200mg BID (FAS) n=82 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 400mg BID (FAS) n=81 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) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study	78.3 percentage of participants	84.0 percentage of participants	80.7 percentage of participants	75.6 percentage of participants	92.6 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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=83 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=81 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=83 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 200mg BID (FAS) n=82 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 400mg BID (FAS) n=81 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	8.4 percentage of participants	7.4 percentage of participants	12.0 percentage of participants	18.3 percentage of participants	25.9 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 an 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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=83 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=81 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=83 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 200mg BID (FAS) n=82 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 400mg BID (FAS) n=81 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) During the Entire Study	4.8 percentage of participants	7.4 percentage of participants	4.8 percentage of participants	6.1 percentage of participants	6.2 percentage of participants

SECONDARY outcome

Timeframe: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

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

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=81 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=80 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=82 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 200mg BID (FAS) n=81 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 400mg BID (FAS) n=81 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 Over the 12 Week Maintenance Period	6.2 percentage of participants	13.8 percentage of participants	12.2 percentage of participants	11.1 percentage of participants	16.0 percentage of participants

SECONDARY outcome

Timeframe: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

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

Outcome measures
Measure	Placebo (FAS) n=81 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=80 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=82 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 200mg BID (FAS) n=81 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 400mg BID (FAS) n=81 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 Over the 12 Week Maintenance Period	21.0 percentage of participants	33.8 percentage of participants	31.7 percentage of participants	25.9 percentage of participants	32.1 percentage of participants

SECONDARY outcome

Timeframe: End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization

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) was assessed.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=81 Participants Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Full Analysis Set (FAS).	Padsevonil 50mg BID (FAS) n=80 Participants Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the FAS.	Padsevonil 100mg BID (FAS) n=82 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 200mg BID (FAS) n=81 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 400mg BID (FAS) n=81 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	12.49 percent change Standard Deviation 58.26	24.70 percent change Standard Deviation 46.62	25.25 percent change Standard Deviation 51.73	20.79 percent change Standard Deviation 66.54	15.79 percent change Standard Deviation 67.55

Adverse Events

Placebo Treatment Period (SS)

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Padsevonil 50mg BID Treatment Period (SS)

Serious events: 5 serious events

Other events: 54 other events

Deaths: 0 deaths

Padsevonil 100mg BID Treatment Period (SS)

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

Padsevonil 200mg BID Treatment Period (SS)

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

Padsevonil 400mg BID Treatment Period (SS)

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo Conversion Period (SS)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Padsevonil 50mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Padsevonil 100mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Padsevonil 200mg BID Conversion Period (SS)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Padsevonil 400mg BID Conversion Period (SS)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Taper and SFU Period (SS)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Padsevonil 50mg BID Taper and SFU Period (SS)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Padsevonil 100mg BID Taper and SFU Period (SS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Padsevonil 200mg BID Taper and SFU Period (SS)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Padsevonil 400mg BID Taper and SFU Period (SS)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Treatment Period (SS) n=83 participants at risk Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Safety Set (SS).	Padsevonil 50mg BID Treatment Period (SS) n=81 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.	Padsevonil 100mg BID Treatment Period (SS) n=83 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 200mg BID Treatment Period (SS) n=82 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 400mg BID Treatment Period (SS) n=81 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=69 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 400mg/day for the OLE. Participants formed the Safety Set (SS).	Padsevonil 50mg BID Conversion Period (SS) n=64 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 50mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 100mg BID Conversion Period (SS) n=66 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 100mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 200mg BID Conversion Period (SS) n=55 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 200mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 400mg BID Conversion Period (SS) n=57 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 400mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Placebo Taper and SFU Period (SS) n=9 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 50mg BID Taper and SFU Period (SS) n=14 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 50 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 100mg BID Taper and SFU Period (SS) n=11 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 200mg BID Taper and SFU Period (SS) n=24 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 400mg BID Taper and SFU Period (SS) n=22 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.
Nervous system disorders Syncope	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Cardiac disorders Atrial flutter	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Infections and infestations Diverticulitis	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Concussion	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Fall	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Head injury	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.1% 1/14 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Traumatic haemothorax	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Altered state of consciousness	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Encephalopathy	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Focal dyscognitive seizures	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Partial seizures	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Seizure cluster	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Status epilepticus	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Renal and urinary disorders Renal disorder	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Surgical and medical procedures Medical device battery replacement	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Psychiatric disorders Depression	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Psychiatric disorders Acute psychosis	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.

Other adverse events

Other adverse events
Measure	Placebo Treatment Period (SS) n=83 participants at risk Participants randomized to the placebo group received 5-6 placebo tablets to maintain the blinding up to week 19. Participants formed the Safety Set (SS).	Padsevonil 50mg BID Treatment Period (SS) n=81 participants at risk Participants were randomized to receive a combination of tablets of padsevonil 50 mg and placebo (as appropriate) to maintain the blinding, bid up to week 19. Participants formed the SS.	Padsevonil 100mg BID Treatment Period (SS) n=83 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 200mg BID Treatment Period (SS) n=82 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 400mg BID Treatment Period (SS) n=81 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=69 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 400mg/day for the OLE. Participants formed the Safety Set (SS).	Padsevonil 50mg BID Conversion Period (SS) n=64 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 50mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 100mg BID Conversion Period (SS) n=66 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 100mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 200mg BID Conversion Period (SS) n=55 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 200mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Padsevonil 400mg BID Conversion Period (SS) n=57 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 400mg bid was gradually adapted (increased or decreased) in a blinded way to reach the entry dose of 400mg/day for the OLE. Participants formed the SS.	Placebo Taper and SFU Period (SS) n=9 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 50mg BID Taper and SFU Period (SS) n=14 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 50 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 100mg BID Taper and SFU Period (SS) n=11 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 200mg BID Taper and SFU Period (SS) n=24 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 400mg BID Taper and SFU Period (SS) n=22 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.
Infections and infestations Urinary tract infection	2.4% 2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.5% 2/81 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.5% 1/22 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Ear and labyrinth disorders Vertigo	8.4% 7/83 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.7% 3/81 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.4% 2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.7% 3/82 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.9% 4/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Gastrointestinal disorders Nausea	8.4% 7/83 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.9% 4/81 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.4% 7/83 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.4% 2/82 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.6% 7/81 • Number of events 13 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Gastrointestinal disorders Diarrhoea	3.6% 3/83 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.4% 6/81 • Number of events 8 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.6% 3/83 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.1% 5/82 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.9% 4/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.6% 1/64 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/57 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.2% 1/24 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
General disorders Fatigue	12.0% 10/83 • Number of events 10 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	24.7% 20/81 • Number of events 27 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	14.5% 12/83 • Number of events 17 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	17.1% 14/82 • Number of events 22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	24.7% 20/81 • Number of events 21 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.3% 3/69 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.8% 5/64 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.0% 2/66 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.2% 1/24 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
General disorders Gait disturbance	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.5% 2/81 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Infections and infestations Nasopharyngitis	6.0% 5/83 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	10.8% 9/83 • Number of events 13 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.5% 7/82 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.6% 1/64 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Infections and infestations Upper respiratory tract infection	1.2% 1/83 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.5% 2/81 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.6% 1/64 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.1% 1/14 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Fall	4.8% 4/83 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.5% 2/81 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.6% 7/81 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.5% 2/81 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.1% 2/64 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.1% 1/14 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Investigations Platelet count decreased	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Investigations Anticonvulsant drug level increased	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.4% 2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.4% 2/82 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Dizziness	10.8% 9/83 • Number of events 9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	22.2% 18/81 • Number of events 19 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	27.7% 23/83 • Number of events 31 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	23.2% 19/82 • Number of events 25 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	34.6% 28/81 • Number of events 55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.3% 3/69 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.1% 2/64 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.6% 2/55 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.5% 2/57 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.2% 1/24 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.5% 1/22 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Somnolence	12.0% 10/83 • Number of events 11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	23.5% 19/81 • Number of events 24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	28.9% 24/83 • Number of events 29 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	30.5% 25/82 • Number of events 26 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	37.0% 30/81 • Number of events 35 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 4/64 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/55 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.5% 2/57 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Headache	12.0% 10/83 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	21.0% 17/81 • Number of events 29 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	10.8% 9/83 • Number of events 16 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	18.3% 15/82 • Number of events 21 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 9/81 • Number of events 31 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.7% 3/64 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.0% 2/66 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.8% 1/57 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	11.1% 1/9 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.3% 2/24 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.5% 1/22 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Memory impairment	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.7% 3/81 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	9.8% 8/82 • Number of events 9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	17.3% 14/81 • Number of events 14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.5% 1/22 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Tremor	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	2.4% 2/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.3% 6/82 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Balance disorder	1.2% 1/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.7% 3/81 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.6% 3/83 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.1% 5/82 • Number of events 5 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	3.7% 3/81 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Nervous system disorders Nystagmus	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.1% 1/14 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Psychiatric disorders Irritability	9.6% 8/83 • Number of events 8 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.9% 4/81 • Number of events 4 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.4% 7/83 • Number of events 7 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/82 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	6.2% 5/81 • Number of events 6 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.6% 1/64 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.5% 1/66 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	4.5% 1/22 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Psychiatric disorders Anxiety	3.6% 3/83 • Number of events 3 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/81 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.2% 1/83 • Number of events 2 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	8.5% 7/82 • Number of events 9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	1.4% 1/69 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/14 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.
Psychiatric disorders Paranoia	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/83 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/82 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/81 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/69 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/64 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/66 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/55 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/57 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/9 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	7.1% 1/14 • Number of events 1 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/11 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/24 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.	0.00% 0/22 • Treatment-emergent AEs were collected from Baseline to Safety Follow-Up (up to Week 23) Adverse events refer to the SS which consisted of all participants who were administered at least 1 dose or a partial dose of IMP. TEAEs counts are for each study period: Treatment Period, Conversion Period for participants who entered the OLE study and Taper Period followed by SFU for participants not entering OLE study.

Additional Information

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Phone: +1844 599

Email: [email protected]

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Principal investigator is a sponsor employee
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