Trial Outcomes & Findings for A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome (NCT NCT02682927)

Last Updated: 2023-09-28

Results Overview

Monthly (28 day) convulsive seizure frequency (CSF) was based on electronic diary data obtained for each participant. Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). The number of convulsive seizures reported during the entire time interval was divided by the number of nonmissing diary days and the result was then multiplied by 28 to get a 28-day CSF.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

262 participants

Primary outcome timeframe

From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Results posted on

2023-09-28

Participant Flow

The study 1501 started to enroll participants in January 2016 and concluded in July 2020. The study 1502 started to enroll participants in July 2016 and concluded in July 2020. The consolidated results of Study 1 and Study 3 are included in this record. The Participant Flow refers to the Randomized Population.

Due to slow enrollment into both trials, the databases for the two trials were combined. The first 72 enrolled participants from ZX008-1501 and first 47 from ZX008-1502 were combined for an analysis and reported as Study 1, whereas the final 55 participants from ZX008- 1501 and the final 88 from ZX008-1502 were combined and reported as Study 3.

Participant milestones

Participant milestones
Measure	Study 1: Placebo Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Overall Study STARTED	40	39	40	48	46	49
Overall Study COMPLETED	37	39	34	43	45	46
Overall Study NOT COMPLETED	3	0	6	5	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study 1: Placebo Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Overall Study Adverse Event	0	5	1	0	2
Overall Study Death	0	0	1	0	0
Overall Study Lack of Efficacy	1	0	1	0	0
Overall Study Other	0	0	2	0	0
Overall Study Withdrawal by Subject	2	1	0	1	1

Baseline Characteristics

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.2 mg/kg/Day n=39 Participants Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=40 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=48 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=49 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Total n=262 Participants Total of all reporting groups
Age, Continuous	9.2 years STANDARD_DEVIATION 5.10 • n=5 Participants	9.0 years STANDARD_DEVIATION 4.52 • n=7 Participants	8.8 years STANDARD_DEVIATION 4.41 • n=5 Participants	9.0 years STANDARD_DEVIATION 4.29 • n=4 Participants	9.6 years STANDARD_DEVIATION 4.42 • n=21 Participants	9.5 years STANDARD_DEVIATION 5.29 • n=10 Participants	9.2 years STANDARD_DEVIATION 4.65 • n=115 Participants
Age, Customized 24 Months - <12 Years	27 Participants n=5 Participants	28 Participants n=7 Participants	31 Participants n=5 Participants	31 Participants n=4 Participants	30 Participants n=21 Participants	30 Participants n=10 Participants	177 Participants n=115 Participants
Age, Customized 12 - < 18 Years	10 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants	15 Participants n=21 Participants	16 Participants n=10 Participants	76 Participants n=115 Participants
Age, Customized 18 - < 65 Years	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	9 Participants n=115 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	22 Participants n=21 Participants	27 Participants n=10 Participants	125 Participants n=115 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	27 Participants n=4 Participants	24 Participants n=21 Participants	22 Participants n=10 Participants	137 Participants n=115 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	36 Participants n=4 Participants	37 Participants n=21 Participants	34 Participants n=10 Participants	205 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=10 Participants	27 Participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	13 Participants n=115 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	10 Participants n=115 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants

PRIMARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=40 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=48 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline in the Mean Convulsive Seizures Frequency (MCSF) to the Combined Titration and Maintenance Periods (T+M) in Participants Receiving ZX008 0.8 mg/kg/Day Compared to Placebo	-6.71 seizure frequency per 28 days Standard Deviation 24.263	-13.11 seizure frequency per 28 days Standard Deviation 25.500	1.54 seizure frequency per 28 days Standard Deviation 21.966	-3.54 seizure frequency per 28 days Standard Deviation 124.132	—	—

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=48 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=46 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline in the Mean Convulsive Seizures Frequency to the Combined Titration and Maintenance Period (T+M) in Participants Receiving ZX008 0.2 mg/kg/Day Compared to Placebo	-6.71 seizure frequency per 28 days Standard Deviation 24.263	-18.81 seizure frequency per 28 days Standard Deviation 90.640	1.54 seizure frequency per 28 days Standard Deviation 21.966	-5.89 seizure frequency per 28 days Standard Deviation 84.735	—	—

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 25% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants Who Achieved Greater Than or Equal to 25% (≥25%) Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period	35.0 percentage of participants	66.7 percentage of participants	90.0 percentage of participants	27.1 percentage of participants	71.7 percentage of participants	83.3 percentage of participants

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 50% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants Who Achieved a ≥50% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period	12.5 percentage of participants	38.5 percentage of participants	67.5 percentage of participants	6.3 percentage of participants	45.7 percentage of participants	72.9 percentage of participants

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 75% or greater reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants Who Achieved a ≥75% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period	2.5 percentage of participants	23.1 percentage of participants	50.0 percentage of participants	4.2 percentage of participants	28.3 percentage of participants	47.9 percentage of participants

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). A responder was a participant who experienced a 100% reduction in convulsive seizure frequency per 28 days during Titration and Maintenance Period.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants Who Achieved a 100% Reduction in Convulsive Seizure Frequency in Each ZX008 Treatment Arm Compared to Placebo From Baseline During the Titration and Maintenance Period	0 percentage of participants	7.7 percentage of participants	7.5 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants

SECONDARY outcome

Timeframe: During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

The longest interval between convulsive seizures was calculated over the entire Titration and Maintenance Period and was derived as the maximum of the number of days between consecutive convulsive seizures.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Longest Convulsive Seizure-free Interval in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period	9.50 days Interval 2.0 to 23.0	15.00 days Interval 3.0 to 106.0	25.00 days Interval 2.0 to 97.0	10 days Interval 2.0 to 65.0	18.5 days Interval 2.0 to 100.0	30 days Interval 2.0 to 104.0

SECONDARY outcome

Timeframe: During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

A convulsive seizure free day was defined as a day for which diary data are available and no convulsive seizures were reported. Convulsive seizure free days were taken from the electronic diary data.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Number of Convulsive Seizure-free Days in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period	15.14 seizure free days Interval 1.1 to 25.6	20.86 seizure free days Interval 2.2 to 28.0	24.43 seizure free days Interval 1.0 to 28.0	20.20 seizure free days Interval 1.4 to 27.1	23.36 seizure free days Interval 0.8 to 27.7	25.33 seizure free days Interval 0.3 to 28.0

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Non-convulsive seizures included focal without clear observable motor signs, absence or atypical absence, myoclonic and atonic. The number of non-convulsive seizures reported during the entire time interval was divided by the number of nonmissing diary days and the result was then multiplied by 28 to get a 28-day non-convulsive seizure frequency.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=21 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=23 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=24 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=26 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=25 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=30 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline in Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo	-9.38 seizure frequency per 28 days Interval -198.8 to 1886.1	-4.85 seizure frequency per 28 days Interval -1940.8 to 192.3	-20.06 seizure frequency per 28 days Interval -2064.8 to 9.4	-0.68 seizure frequency per 28 days Interval -160.0 to 1313.1	-0.67 seizure frequency per 28 days Interval -138.7 to 111.3	-4.35 seizure frequency per 28 days Interval -1410.6 to 107.5

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Total seizure frequency were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). Non-convulsive seizures included focal without clear observable motor signs, absence or atypical absence, myoclonic and atonic. The seizure frequency was based on electronic diary data obtained for each participant. The number of all seizures reported during the entire time interval was divided by the number of nonmissing diary days and the result was then multiplied by 28 to get a 28-day convulsive or non-convulsive seizure frequency.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline in Convulsive + Non-convulsive Seizure Frequency to the Combined Titration and Maintenance Period in Each ZX008 Treatment Arm Compared to Placebo	-4.45 seizure frequency per 28 days Interval -198.4 to 1850.1	-7.40 seizure frequency per 28 days Interval -1955.1 to 187.1	-22.95 seizure frequency per 28 days Interval -2069.3 to 44.5	-1.09 seizure frequency per 28 days Interval -160.1 to 1310.5	-6.54 seizure frequency per 28 days Interval -153.0 to 525.9	-11.39 seizure frequency per 28 days Interval -1504.8 to 791.4

SECONDARY outcome

Timeframe: From Baseline up to 14 weeks [Titration Period (2 weeks) plus Maintenance Period (12 weeks)]

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Rescue medication was administered according to each participant's usual or prescribed regimen consisting of 1 or more medications. The usage of rescue medication (number of days and number of medications used per seizure episode) was based on electronic diary data obtained for each participant. The number of days rescue medication was taken (normalized to 28 days) was calculated for each participant. Multiple medications taken on the same day were counted once for that day.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants With Rescue Medication Usage in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period	77.5 percentage of participants	59.0 percentage of participants	45.0 percentage of participants	60.4 percentage of participants	65.2 percentage of participants	47.9 percentage of participants

SECONDARY outcome

Timeframe: During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Participants who utilized medical center care to treat a seizure during the study were reported.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants With Hospitalization and Healthcare Resource Utilization to Treat Seizures in Each ZX008 Treatment Arm Compared to Placebo During Study	22.5 percentage of participants	17.9 percentage of participants	15.0 percentage of participants	12.5 percentage of participants	19.6 percentage of participants	14.6 percentage of participants

SECONDARY outcome

Timeframe: During 14 weeks Titration (2 weeks) and Maintenance Period (12 weeks) (average of 99 days)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

The participants who either had SE episode recorded as an adverse event (AE) during treatment or a seizure greater than 10 minutes were reported for each treatment group. Additionally, a single participant who may had more than one episode of SE, and an episode of SE recorded as both an AE and as a seizure longer than 10 minutes was counted as a single event.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants With Status Epilepticus (SE) in Each ZX008 Treatment Arm Compared to Placebo During the Titration and Maintenance Period	27.5 percentage of participants	28.2 percentage of participants	35.0 percentage of participants	16.7 percentage of participants	19.6 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: At Baseline and 14 weeks of Titration (2 weeks) and Maintenance Period (12 weeks)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

Duration of single convulsive seizures during the Baseline and the duration over the Titration and Maintenance Period were reported by treatment group using categories as \<2 minutes, 2 to 10 minutes and \> 10 minutes as collected in the seizure diary.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period >10 min (Baseline)	3.86 percentage of seizures	0.93 percentage of seizures	4.17 percentage of seizures	0.96 percentage of seizures	2.45 percentage of seizures	3.10 percentage of seizures
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period <2 min (Baseline)	69.28 percentage of seizures	64.13 percentage of seizures	71.61 percentage of seizures	64.21 percentage of seizures	63.90 percentage of seizures	74.11 percentage of seizures
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period 2-10 min (Baseline)	26.86 percentage of seizures	34.95 percentage of seizures	24.22 percentage of seizures	34.83 percentage of seizures	33.66 percentage of seizures	22.78 percentage of seizures
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period <2 min (Titration + Maintenance Period)	71.31 percentage of seizures	71.59 percentage of seizures	72.27 percentage of seizures	65.84 percentage of seizures	63.45 percentage of seizures	84.67 percentage of seizures
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period 2-10 min (Titration + Maintenance Period)	26.31 percentage of seizures	25.61 percentage of seizures	22.91 percentage of seizures	33.74 percentage of seizures	31.34 percentage of seizures	13.71 percentage of seizures
Distribution of Duration of Convulsive Seizures (in Percentage) in Each ZX008 Treatment Arm Compared to Placebo at Baseline and During the Titration and Maintenance Period >10 min (Titration + Maintenance Period)	2.38 percentage of seizures	2.79 percentage of seizures	4.82 percentage of seizures	0.43 percentage of seizures	5.22 percentage of seizures	1.62 percentage of seizures

SECONDARY outcome

Timeframe: At Visit 6 (Day 15), 8 (Day 43), 10 (Day 71) and 12 (Day 99)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

CGI-I scale measures improvement in the participant's clinical status from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse. The Principal Investigator rated their global impression of the participant's condition during the study.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 8)	0 percentage of participants	5.1 percentage of participants	17.5 percentage of participants	4.2 percentage of participants	17.4 percentage of participants	29.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 8)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 6)	20.0 percentage of participants	20.5 percentage of participants	20.0 percentage of participants	27.1 percentage of participants	17.4 percentage of participants	27.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 6)	40.0 percentage of participants	25.6 percentage of participants	17.5 percentage of participants	54.2 percentage of participants	26.1 percentage of participants	12.5 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 6)	5.0 percentage of participants	7.7 percentage of participants	5.0 percentage of participants	4.2 percentage of participants	2.2 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 6)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 6)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 8)	12.5 percentage of participants	30.8 percentage of participants	37.5 percentage of participants	6.3 percentage of participants	10.9 percentage of participants	31.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 8)	30.0 percentage of participants	20.5 percentage of participants	10.0 percentage of participants	16.7 percentage of participants	26.1 percentage of participants	14.6 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 8)	30.0 percentage of participants	17.9 percentage of participants	10.0 percentage of participants	50.0 percentage of participants	34.8 percentage of participants	8.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 8)	5.0 percentage of participants	5.1 percentage of participants	0 percentage of participants	4.2 percentage of participants	0 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 8)	2.5 percentage of participants	5.1 percentage of participants	2.5 percentage of participants	2.1 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 10)	2.5 percentage of participants	17.9 percentage of participants	20.0 percentage of participants	4.2 percentage of participants	15.2 percentage of participants	35.4 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 10)	7.5 percentage of participants	17.9 percentage of participants	47.5 percentage of participants	10.4 percentage of participants	19.6 percentage of participants	18.8 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 10)	30.0 percentage of participants	25.6 percentage of participants	5.0 percentage of participants	12.5 percentage of participants	26.1 percentage of participants	16.7 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 10)	35.0 percentage of participants	28.2 percentage of participants	7.5 percentage of participants	60.4 percentage of participants	28.3 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 10)	10.0 percentage of participants	7.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 10)	0 percentage of participants	2.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 10)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 12)	2.5 percentage of participants	12.8 percentage of participants	27.5 percentage of participants	4.2 percentage of participants	8.7 percentage of participants	33.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 12)	7.5 percentage of participants	28.2 percentage of participants	35.0 percentage of participants	4.2 percentage of participants	28.3 percentage of participants	31.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 12)	30.0 percentage of participants	17.9 percentage of participants	15.0 percentage of participants	16.7 percentage of participants	21.7 percentage of participants	10.4 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 12)	47.5 percentage of participants	28.2 percentage of participants	12.5 percentage of participants	58.3 percentage of participants	28.3 percentage of participants	16.7 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 12)	2.5 percentage of participants	10.3 percentage of participants	0 percentage of participants	6.3 percentage of participants	10.9 percentage of participants	6.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 12)	2.5 percentage of participants	2.6 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 12)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 6)	5.0 percentage of participants	23.1 percentage of participants	17.5 percentage of participants	4.2 percentage of participants	21.7 percentage of participants	16.7 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Rating Score, as Assessed by the Principal Investigator in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 6)	12.5 percentage of participants	12.8 percentage of participants	25.0 percentage of participants	2.1 percentage of participants	21.7 percentage of participants	27.1 percentage of participants

SECONDARY outcome

Timeframe: At Visit 6 (Day 15), 8 (Day 43), 10 (Day 71) and 12 (Day 99)

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

CGI-I scale measures improvement in the participant's clinical status from Baseline. The severity of a participant's condition was rated on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), as follows: 1-very much improved,2-much improved, 3-minimally improved, 4- no change, 5-minimally worse, 6-much worse and 7-very much worse. The Parent/Caregiver rated their global impression of the participant's condition during the study.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 6)	22.5 percentage of participants	20.5 percentage of participants	27.5 percentage of participants	2.1 percentage of participants	23.9 percentage of participants	31.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 6)	2.5 percentage of participants	17.9 percentage of participants	15.0 percentage of participants	6.3 percentage of participants	13.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 6)	12.5 percentage of participants	28.2 percentage of participants	22.5 percentage of participants	25.0 percentage of participants	26.1 percentage of participants	31.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 6)	45.0 percentage of participants	12.8 percentage of participants	20.0 percentage of participants	45.8 percentage of participants	19.6 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 6)	2.5 percentage of participants	7.7 percentage of participants	2.5 percentage of participants	10.4 percentage of participants	2.2 percentage of participants	6.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 6)	5.0 percentage of participants	2.6 percentage of participants	7.5 percentage of participants	2.1 percentage of participants	2.2 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 6)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 8)	0 percentage of participants	15.4 percentage of participants	20.0 percentage of participants	4.2 percentage of participants	6.5 percentage of participants	39.6 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 8)	15.0 percentage of participants	25.6 percentage of participants	37.5 percentage of participants	8.3 percentage of participants	30.4 percentage of participants	29.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 8)	25.0 percentage of participants	25.6 percentage of participants	15.0 percentage of participants	20.8 percentage of participants	28.3 percentage of participants	14.6 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 8)	20.0 percentage of participants	12.8 percentage of participants	5.0 percentage of participants	47.9 percentage of participants	17.4 percentage of participants	6.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 8)	15.0 percentage of participants	10.3 percentage of participants	2.5 percentage of participants	6.3 percentage of participants	6.5 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 8)	2.5 percentage of participants	5.1 percentage of participants	5.0 percentage of participants	4.2 percentage of participants	2.2 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 8)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	4.2 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 10)	2.5 percentage of participants	20.5 percentage of participants	35.0 percentage of participants	2.1 percentage of participants	8.7 percentage of participants	41.7 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 10)	12.5 percentage of participants	17.9 percentage of participants	30.0 percentage of participants	6.3 percentage of participants	28.3 percentage of participants	22.9 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 10)	22.5 percentage of participants	20.5 percentage of participants	7.5 percentage of participants	25.0 percentage of participants	26.1 percentage of participants	8.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 10)	32.5 percentage of participants	25.6 percentage of participants	10.0 percentage of participants	45.8 percentage of participants	26.1 percentage of participants	6.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 10)	12.5 percentage of participants	7.7 percentage of participants	0 percentage of participants	6.3 percentage of participants	0 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 10)	2.5 percentage of participants	7.7 percentage of participants	0 percentage of participants	0 percentage of participants	4.3 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 10)	2.5 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 1 = Very much improved (Visit 12)	2.5 percentage of participants	20.5 percentage of participants	27.5 percentage of participants	2.1 percentage of participants	6.5 percentage of participants	33.3 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 2 = Much improved (Visit 12)	7.5 percentage of participants	20.5 percentage of participants	27.5 percentage of participants	6.3 percentage of participants	28.3 percentage of participants	29.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 3 = Minimally improved (Visit 12)	20.0 percentage of participants	15.4 percentage of participants	10.0 percentage of participants	18.8 percentage of participants	30.4 percentage of participants	20.8 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 4 = No change (Visit 12)	35.0 percentage of participants	20.5 percentage of participants	15.0 percentage of participants	50.0 percentage of participants	13.0 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 5 = Minimally worse (Visit 12)	17.5 percentage of participants	15.4 percentage of participants	5.0 percentage of participants	10.4 percentage of participants	8.7 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 6 = Much worse (Visit 12)	7.5 percentage of participants	7.7 percentage of participants	5.0 percentage of participants	2.1 percentage of participants	4.3 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinical Global Impression - Improvement Rating Score, as Assessed by the Parent/Caregiver in Each ZX008 Treatment Arm Compared to Placebo 7 = Very much worse (Visit 12)	0 percentage of participants	0 percentage of participants	2.5 percentage of participants	0 percentage of participants	2.2 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Day 99

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

QOLCE is a low-burden parent/caregiver completed assessment that evaluates how epilepsy affects day-to day functioning of the participant in various life areas, including physical activities, well being, cognition, social activities, behavior, and general health. QOLCE scores items on 16 subscales with possible 5-point response for each, where scores of 5 was best possible response and 1 was worst possible response. Item scores were then transformed to a 0-100 scale as follows: 1-0, 2-25, 3-50, 4-75, 5-100. A score for each participant for each subscale was calculated by averaging that participant's responses to each item in the subscale. Subscale scores per participant were averaged to obtain an overall QoL score for each participant. Higher the subscale and overall QoL scores, better the response.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline to Day 99 in the Quality of Life in Childhood Epilepsy (QOLCE) Score to Measure Quality of Life in Each ZX008 Treatment Arm Compared to Placebo	1.5 score on a scale Standard Deviation 8.73	0.8 score on a scale Standard Deviation 11.77	5.8 score on a scale Standard Deviation 11.70	1.2 score on a scale Standard Deviation 9.01	6.1 score on a scale Standard Deviation 12.47	5.5 score on a scale Standard Deviation 13.22

SECONDARY outcome

Timeframe: From Baseline to Day 99

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available.

The Pediatric Quality of Life Inventory (PedsQL) is a pediatric modular measure of health related quality of life (QoL) completed by the parent/caregiver on behalf of the participant. It consisted of 23 items across 4 core scales that measure physical (8 items), emotional, social, and school functioning (5 items each). Each of the responses to the 23 items is initially scored on a 5-point Likert scale from 0 (Never) to 4 (Almost always). Scores are linearly transformed to a scale of 0 to 100, where 0=100, 1=75, 2=50, 3=25 and 4=0, and higher scores correspond to better health-related QoL. The Overall Quality of Life is the average of all the items over the number of items answered on all the Scales.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline to Day 99 in the Overall Quality of Life Score From the Pediatric Quality of Life Inventory™ (PedsQL) Score in Each ZX008 Treatment Arm Compared to Placebo	-1.6 score on a scale Standard Deviation 10.43	6.8 score on a scale Standard Deviation 11.25	5.9 score on a scale Standard Deviation 15.11	1.9 score on a scale Standard Deviation 13.26	4.2 score on a scale Standard Deviation 17.65	2.1 score on a scale Standard Deviation 14.73

SECONDARY outcome

Timeframe: From Baseline to Day 99

The PedsQL Family Impact measured the impact of pediatric chronic health conditions on parents and the family by measuring parent self-reported physical, emotional, social, and cognitive functioning, communication, worry, and family daily activities and relationships. There are a total of 36 items in the PedsQL: 6 items for Physical Functioning, 5 items each for Emotional Functioning, Cognitive Functioning and Worry, 4 for Social Functioning, 3 for Communication, 3 questions for Daily Activities, and 5 for Family Relationships. Each of the responses are initially scored on a 5-point Likert scale from 0 (Never) to 4 (Almost always) and then linearly transformed to a scale of 0 to 100, where 0=100, 1=75, 2=50, 3=25 and 4=0, and higher scores mean better health-related QoL.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=40 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=39 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=40 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=47 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=44 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline to Day 99 in the Total Score From PedsQL Family Impact Module Score in Each ZX008 Treatment Arm Compared to Placebo	-4.4 score on a scale Standard Deviation 13.00	3.9 score on a scale Standard Deviation 9.44	5.4 score on a scale Standard Deviation 15.60	1.3 score on a scale Standard Deviation 14.88	0.7 score on a scale Standard Deviation 15.78	6.3 score on a scale Standard Deviation 14.64

SECONDARY outcome

Timeframe: At Baseline and Day 99

Population: The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, Number of participants analyzed included those participants who were evaluable for the assessment and 'n' (Number analyzed) signifies participants who were evaluable at specified time points.

The EuroQOL-5 Dimensions-5 Levels scale produced by European QOL Group (EQ-5D-5L) health questionnaire is a health-related QOL instrument with 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 dimensions of EQ-5D-5L health questionnaire were assessed on a Likert scale with 5 possible levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The categories "slight problems", "moderate problems", "severe problems" and "extreme problems" are collapsed into one response category "problems. The QOL of the parent/caregiver was assessed and percentage of participants was reported for each item.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=39 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=37 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=39 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=42 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=43 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=45 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Self-care - No problems (Baseline)	25.64 percentage of participants	41.18 percentage of participants	38.46 percentage of participants	22.50 percentage of participants	36.36 percentage of participants	22.86 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Self-care - Problems (Baseline)	74.36 percentage of participants	58.82 percentage of participants	61.54 percentage of participants	77.50 percentage of participants	63.64 percentage of participants	77.14 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Self-care - No problems (Day 99)	28.57 percentage of participants	43.24 percentage of participants	48.65 percentage of participants	30.95 percentage of participants	34.88 percentage of participants	35.56 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Usual activities- Problems (Day 99)	74.29 percentage of participants	67.57 percentage of participants	51.35 percentage of participants	69.05 percentage of participants	74.42 percentage of participants	64.44 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Pain/discomfort- No problems (Baseline)	48.72 percentage of participants	41.18 percentage of participants	46.15 percentage of participants	45.00 percentage of participants	51.52 percentage of participants	51.43 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Pain/discomfort- Problems (Baseline)	51.28 percentage of participants	58.82 percentage of participants	53.85 percentage of participants	55.00 percentage of participants	48.48 percentage of participants	48.57 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Pain/discomfort- Problems (Day 99)	51.43 percentage of participants	48.65 percentage of participants	35.14 percentage of participants	45.24 percentage of participants	53.49 percentage of participants	35.56 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Anxiety/depression- No problems (Day 99)	65.71 percentage of participants	67.57 percentage of participants	67.57 percentage of participants	69.05 percentage of participants	67.44 percentage of participants	73.33 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Usual activities- Problems (Baseline)	76.92 percentage of participants	58.82 percentage of participants	64.10 percentage of participants	75.00 percentage of participants	60.61 percentage of participants	80.00 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Self-care - Problems (Day 99)	71.43 percentage of participants	56.76 percentage of participants	51.35 percentage of participants	69.05 percentage of participants	65.12 percentage of participants	64.44 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Usual activities- No problems (Baseline)	23.08 percentage of participants	41.18 percentage of participants	35.90 percentage of participants	25.00 percentage of participants	39.39 percentage of participants	20.00 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Usual activities- No problems (Day 99)	25.71 percentage of participants	32.43 percentage of participants	48.65 percentage of participants	30.95 percentage of participants	25.58 percentage of participants	35.56 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Pain/discomfort- No problems (Day 99)	48.57 percentage of participants	51.35 percentage of participants	64.86 percentage of participants	76.19 percentage of participants	46.51 percentage of participants	64.44 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Anxiety/depression- No problems (Baseline)	74.36 percentage of participants	61.76 percentage of participants	56.41 percentage of participants	60.00 percentage of participants	63.64 percentage of participants	74.29 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Anxiety/depression- Problems (Baseline)	25.64 percentage of participants	38.24 percentage of participants	43.59 percentage of participants	40.00 percentage of participants	36.36 percentage of participants	25.71 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Anxiety/depression- Problems (Day 99)	34.29 percentage of participants	32.43 percentage of participants	32.43 percentage of participants	30.95 percentage of participants	32.56 percentage of participants	26.67 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Mobility- No problems (Baseline)	33.33 percentage of participants	52.94 percentage of participants	46.15 percentage of participants	40.00 percentage of participants	54.55 percentage of participants	28.57 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Mobility- Problems (Baseline)	66.67 percentage of participants	47.06 percentage of participants	53.85 percentage of participants	60.00 percentage of participants	45.45 percentage of participants	71.43 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Mobility- No problems (Day 99)	40.00 percentage of participants	45.95 percentage of participants	51.35 percentage of participants	52.38 percentage of participants	51.16 percentage of participants	46.67 percentage of participants
Quality of Life (QoL) of the Parent/Caregiver Using the EQ- 5D-5L Scale in Each ZX008 Treatment Arm Compared to Placebo at Baseline and Day 99 Mobility- Problems (Day 99)	60.00 percentage of participants	54.05 percentage of participants	48.65 percentage of participants	47.62 percentage of participants	48.84 percentage of participants	53.33 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Day 99

The HADS is a tool that was validated to assess presence of anxiety or depression in an outpatient non-psychiatric population. The HADS a 14-item scale that generates ordinal data for 2 dimensions: 1) Anxiety (7 items), and 2) Depression (7 items). Each item has 4 possible answers rated 0 to 3, of which 0 = No distress and 3 = worst distress. All answers to the items for a dimension with their respective rating are added resulting in a range for each dimension from 0-21, out of which of 0-7 = normal; 8-10=borderline abnormal; 11-21=abnormal. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=31 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=32 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=35 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=30 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=31 Participants Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=27 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Change From Baseline to Day 99 in Affective Symptoms of the Parent/Caregiver Using the Hospital Anxiety and Depression Scale (HADS) in Each ZX008 Treatment Arm Compared to Placebo Depression	0.8 score on a scale Standard Deviation 4.50	0.2 score on a scale Standard Deviation 4.52	0.1 score on a scale Standard Deviation 4.35	-0.7 score on a scale Standard Deviation 3.80	2.0 score on a scale Standard Deviation 4.77	-0.8 score on a scale Standard Deviation 4.03
Change From Baseline to Day 99 in Affective Symptoms of the Parent/Caregiver Using the Hospital Anxiety and Depression Scale (HADS) in Each ZX008 Treatment Arm Compared to Placebo Anxiety	-0.4 score on a scale Standard Deviation 2.68	-0.8 score on a scale Standard Deviation 2.84	-0.8 score on a scale Standard Deviation 3.33	-0.6 score on a scale Standard Deviation 3.62	0.2 score on a scale Standard Deviation 3.89	-0.7 score on a scale Standard Deviation 4.00
Change From Baseline to Day 99 in Affective Symptoms of the Parent/Caregiver Using the Hospital Anxiety and Depression Scale (HADS) in Each ZX008 Treatment Arm Compared to Placebo Total emotional distress	0.4 score on a scale Standard Deviation 6.45	-0.6 score on a scale Standard Deviation 6.60	-0.7 score on a scale Standard Deviation 6.82	-1.2 score on a scale Standard Deviation 6.42	2.2 score on a scale Standard Deviation 7.52	-1.5 score on a scale Standard Deviation 6.61

SECONDARY outcome

Timeframe: At Visit 8 (Day 43): pre-dose, 1, 2, and 4-6 hours postdose

Population: PK population for each study represents participants randomized to ZX008 and provided concentrations for use in the population PK analysis.

Cmax is the maximum observed concentration determined directly from the concentration-time profile.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=39 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=36 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=45 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=44 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Maximum Observed Concentration of ZX008 Determined Directly From the Concentration Time Profile [Cmax] at Steady State	17.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.5	67.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 37.4	17.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.3	64.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.6	—	—

SECONDARY outcome

Timeframe: At Visit 8 (Day 43): pre-dose, 1, 2, and 4-6 hours postdose

Population: PK population for each study represents participants randomized to ZX008 and provided concentrations for use in the population PK analysis. PK samples at Visit 8 (Day 43) taken pre-dose to 6 hours post-dose were used to develop a population PK model. The model was utilized to generate plasma concentration-time curve over 24 hours at steady-state in study participants. AUC0-24 was calculated by numerical integration of the individual predicted concentration-time curve.

AUC0-24 is the area under the concentration time curve from time zero to 24 hours.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=39 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=36 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=45 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=44 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Area Under the Concentration Time Curve of ZX008 From Time Zero to Time 24 Hours [AUC0-24hours] at Steady State	356 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 37.0	1390 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 41.3	348 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 37.1	1290 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 42.6	—	—

SECONDARY outcome

Timeframe: At Visit 8 (Day 43): pre-dose, 1, 2, and 4-6 hours postdose

Population: PK population for each study represents participants randomized to ZX008 and provided concentrations for use in the population PK analysis.

Tmax is the time to maximum concentration at steady state.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=39 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=36 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=45 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=44 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Time to Maximum Concentration [Tmax] of ZX008 at Steady State	2.90 hours (h) Interval 2.8 to 3.1	3.00 hours (h) Interval 2.7 to 3.2	2.90 hours (h) Interval 2.8 to 3.1	2.90 hours (h) Interval 2.7 to 3.2	—	—

SECONDARY outcome

Timeframe: At Visit 8 (Day 43): pre-dose, 1, 2, and 4-6 hours postdose

Population: PK population for each study represents participants randomized to ZX008 and provided concentrations for use in the population PK analysis.

t1/2 beta is the elimination half-life.

Outcome measures

Outcome measures
Measure	Study 1: Placebo n=39 Participants Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=36 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=45 Participants Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=44 Participants Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Elimination Half-life [t1/2 Beta] of ZX008 at Steady State	18.4 hours (h) Geometric Coefficient of Variation 32.3	21.1 hours (h) Geometric Coefficient of Variation 51.8	18.1 hours (h) Geometric Coefficient of Variation 32.1	18.6 hours (h) Geometric Coefficient of Variation 42.2	—	—

Adverse Events

Study 1: Placebo

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Study 1: ZX008 0.2 mg/kg/Day

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Study 1: ZX008 0.8 mg/kg/Day

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Study 3: Placebo

Serious events: 2 serious events

Other events: 37 other events

Deaths: 1 deaths

Study 3: ZX008 0.2 mg/kg/Day

Serious events: 3 serious events

Other events: 41 other events

Deaths: 0 deaths

Study 3: ZX008 0.8 mg/kg/Day

Serious events: 3 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study 1: Placebo n=40 participants at risk Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.2 mg/kg/Day n=39 participants at risk Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=40 participants at risk Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=48 participants at risk Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 participants at risk Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 participants at risk Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Nervous system disorders Seizure	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Somnolence	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Adverse drug reaction	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Sudden unexplained death in epilepsy	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Gastroenteritis	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Gastroenteritis viral	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Lower respiratory tract infection	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Pneumonia	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Varicella	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Injury, poisoning and procedural complications Head injury	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Hepatic enzyme increased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Weight decreased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Febrile convulsion	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Generalised tonic-clonic seizure	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Lethargy	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Status epilepticus	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.

Other adverse events

Other adverse events
Measure	Study 1: Placebo n=40 participants at risk Participants received matching placebo as an oral solution, twice a day (bid) in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.2 mg/kg/Day n=39 participants at risk Participants received ZX008 0.2 milligram per kilogram per day (mg/kg/day) as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 1: ZX008 0.8 mg/kg/Day n=40 participants at risk Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 1 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: Placebo n=48 participants at risk Participants received matching placebo as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.2 mg/kg/Day n=46 participants at risk Participants received ZX008 0.2 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.	Study 3: ZX008 0.8 mg/kg/Day n=48 participants at risk Participants received ZX008 0.8 mg/kg/day as an oral solution, bid, in equally divided doses with food for up to approximately 16 weeks. Study 3 is the merged analysis of 2 identical (ZX008-1501 and ZX008-1502) studies.
Gastrointestinal disorders Diarrhoea	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	30.8% 12/39 • Number of events 14 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	17.5% 7/40 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	15.2% 7/46 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	14.6% 7/48 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Gastrointestinal disorders Vomiting	10.0% 4/40 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.3% 4/39 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Fatigue	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.3% 4/39 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.0% 4/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.4% 5/48 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Pyrexia	20.0% 8/40 • Number of events 12 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	17.9% 7/39 • Number of events 12 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.9% 5/46 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	18.8% 9/48 • Number of events 11 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Nasopharyngitis	12.5% 5/40 • Number of events 6 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.3% 4/39 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	17.5% 7/40 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.4% 5/48 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.7% 4/46 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Upper respiratory tract infection	12.5% 5/40 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	20.5% 8/39 • Number of events 13 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Blood glucose decreased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	12.5% 6/48 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	23.9% 11/46 • Number of events 13 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	16.7% 8/48 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Blood pressure diastolic increased	2.5% 1/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Echocardiogram abnormal	12.5% 5/40 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	17.9% 7/39 • Number of events 7 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	22.5% 9/40 • Number of events 13 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.4% 5/48 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	23.9% 11/46 • Number of events 11 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	16.7% 8/48 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Metabolism and nutrition disorders Decreased appetite	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	20.5% 8/39 • Number of events 11 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	35.0% 14/40 • Number of events 15 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	26.1% 12/46 • Number of events 12 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	37.5% 18/48 • Number of events 22 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Lethargy	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.3% 4/39 • Number of events 6 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	17.5% 7/40 • Number of events 8 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Somnolence	7.5% 3/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	15.4% 6/39 • Number of events 6 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.4% 5/48 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.9% 5/46 • Number of events 6 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	20.8% 10/48 • Number of events 10 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Gastrointestinal disorders Constipation	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.0% 4/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Asthenia	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
General disorders Gait disturbance	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Croup infectious	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Ear infection	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Influenza	10.0% 4/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Rhinitis	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Sinusitis	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Urinary tract infection	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Infections and infestations Viral infection	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Injury, poisoning and procedural complications Fall	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	10.3% 4/39 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Blood pressure increased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Blood pressure systolic increased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Blood prolactin increased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Heart rate increased	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Platelet count decreased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Investigations Weight decreased	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	12.8% 5/39 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Ataxia	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Balance disorder	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Drooling	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Hypotonia	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Sedation	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Seizure	10.0% 4/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.7% 3/39 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Seizure cluster	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Status epilepticus	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 5 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Nervous system disorders Tremor	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	12.5% 6/48 • Number of events 6 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Psychiatric disorders Abnormal behaviour	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	7.5% 3/40 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.2% 1/46 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.2% 2/48 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Psychiatric disorders Enuresis	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Psychiatric disorders Irritability	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/39 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Psychiatric disorders Negativism	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Renal and urinary disorders Urinary incontinence	0.00% 0/40 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.6% 1/39 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	4.3% 2/46 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.2% 3/48 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.5% 1/40 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/48 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	6.5% 3/46 • Number of events 3 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.
Skin and subcutaneous tissue disorders Rash	2.5% 1/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.1% 2/39 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	5.0% 2/40 • Number of events 2 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	2.1% 1/48 • Number of events 1 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	0.00% 0/46 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.	8.3% 4/48 • Number of events 4 • From Titration Period until the Safety Follow-up Visit (up to Day 113) A Treatment emergent adverse event (TEAE) was defined as any AE that based on start date information occurred after the first dose of study drug. The safety population included all randomized participants who received at least 1 dose of ZX008 or placebo.

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60