Trial Outcomes & Findings for A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures (NCT NCT01866111)

Last Updated: 2025-06-24

Results Overview

Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

437 participants

Primary outcome timeframe

baseline and 18 weeks

Results posted on

2025-06-24

Participant Flow

533 subjects were screened and 96 were excluded for the following reasons: did not meet eligibility criteria (n=83) and withdrew consent (n=13).

Participant milestones

Participant milestones
Measure	Placebo Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day Subjects titrated to a target dose of 400 mg/day
Double-blind Period of Study YKP3089C017 STARTED	108	108	110	111
Double-blind Period of Study YKP3089C017 COMPLETED	94	95	90	81
Double-blind Period of Study YKP3089C017 NOT COMPLETED	14	13	20	30
Open-label Extension Study YKP3089C017 STARTED	91	95	90	80
Open-label Extension Study YKP3089C017 COMPLETED	16	21	19	14
Open-label Extension Study YKP3089C017 NOT COMPLETED	75	74	71	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day Subjects titrated to a target dose of 400 mg/day
Double-blind Period of Study YKP3089C017 Adverse Event	5	12	15	23
Double-blind Period of Study YKP3089C017 Withdrawal by Subject	5	0	4	3
Double-blind Period of Study YKP3089C017 Protocol Violation	0	0	1	1
Double-blind Period of Study YKP3089C017 Lack of Efficacy	0	1	0	1
Double-blind Period of Study YKP3089C017 Lost to Follow-up	0	0	0	1
Double-blind Period of Study YKP3089C017 Pregnancy	1	0	0	0
Double-blind Period of Study YKP3089C017 Reason Unknown	3	0	0	1
Open-label Extension Study YKP3089C017 Adverse Event	9	6	6	7
Open-label Extension Study YKP3089C017 Withdrawal by Subject	16	7	9	3
Open-label Extension Study YKP3089C017 Protocol Violation	1	0	0	2
Open-label Extension Study YKP3089C017 Lost to Follow-up	2	1	1	3
Open-label Extension Study YKP3089C017 Death	1	1	3	2
Open-label Extension Study YKP3089C017 Entered Expanded Access Program	30	39	28	32
Open-label Extension Study YKP3089C017 Lack of Efficacy	13	17	23	14
Open-label Extension Study YKP3089C017 Reason Unknown	3	3	1	3

Baseline Characteristics

Baseline seizure frequency was analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=108 Participants Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day n=108 Participants Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day n=110 Participants Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day n=111 Participants Subjects titrated to a target dose of 400 mg/day	Total n=437 Participants Total of all reporting groups
Age, Continuous	38 Years n=108 Participants	37.5 Years n=108 Participants	40.5 Years n=110 Participants	38.0 Years n=111 Participants	38 Years n=437 Participants
Sex: Female, Male Female	50 Participants n=108 Participants	51 Participants n=108 Participants	56 Participants n=110 Participants	59 Participants n=111 Participants	216 Participants n=437 Participants
Sex: Female, Male Male	58 Participants n=108 Participants	57 Participants n=108 Participants	54 Participants n=110 Participants	52 Participants n=111 Participants	221 Participants n=437 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=108 Participants	8 Participants n=108 Participants	7 Participants n=110 Participants	13 Participants n=111 Participants	37 Participants n=437 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=108 Participants	100 Participants n=108 Participants	103 Participants n=110 Participants	98 Participants n=111 Participants	400 Participants n=437 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=108 Participants	0 Participants n=108 Participants	0 Participants n=110 Participants	0 Participants n=111 Participants	0 Participants n=437 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=108 Participants	0 Participants n=108 Participants	0 Participants n=110 Participants	0 Participants n=111 Participants	0 Participants n=437 Participants
Race (NIH/OMB) Asian	9 Participants n=108 Participants	10 Participants n=108 Participants	11 Participants n=110 Participants	11 Participants n=111 Participants	41 Participants n=437 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=108 Participants	0 Participants n=108 Participants	0 Participants n=110 Participants	0 Participants n=111 Participants	0 Participants n=437 Participants
Race (NIH/OMB) Black or African American	4 Participants n=108 Participants	4 Participants n=108 Participants	3 Participants n=110 Participants	1 Participants n=111 Participants	12 Participants n=437 Participants
Race (NIH/OMB) White	93 Participants n=108 Participants	89 Participants n=108 Participants	94 Participants n=110 Participants	96 Participants n=111 Participants	372 Participants n=437 Participants
Race (NIH/OMB) More than one race	0 Participants n=108 Participants	0 Participants n=108 Participants	0 Participants n=110 Participants	0 Participants n=111 Participants	0 Participants n=437 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=108 Participants	5 Participants n=108 Participants	2 Participants n=110 Participants	3 Participants n=111 Participants	12 Participants n=437 Participants
28-day partial-onset seizure frequency	8.4 seizures/28 days n=106 Participants • Baseline seizure frequency was analyzed	9.5 seizures/28 days n=108 Participants • Baseline seizure frequency was analyzed	11.0 seizures/28 days n=109 Participants • Baseline seizure frequency was analyzed	9.0 seizures/28 days n=111 Participants • Baseline seizure frequency was analyzed	9.4 seizures/28 days n=434 Participants • Baseline seizure frequency was analyzed

PRIMARY outcome

Timeframe: baseline and 18 weeks

Population: All randomly assigned patients who took at least one dose of study drug and had any post-baseline seizure data.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day n=108 Participants Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day n=109 Participants Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day n=111 Participants Subjects titrated to a target dose of 400 mg/day
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	-24.0 percent change Interval -91.0 to 198.0	-35.5 percent change Interval -100.0 to 206.0	-55.0 percent change Interval -100.0 to 191.0	-55.0 percent change Interval -100.0 to 167.0

SECONDARY outcome

Timeframe: 18 weeks

Population: All randomly assigned patients who had taken at least one dose of study drug and had any post-baseline seizure data

Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day n=108 Participants Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day n=109 Participants Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day n=111 Participants Subjects titrated to a target dose of 400 mg/day
50% Responder Rate	23 Participants	44 Participants	63 Participants	67 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 76 other events

Deaths: 0 deaths

Cenobamate 100 mg/Day

Serious events: 10 serious events

Other events: 70 other events

Deaths: 0 deaths

Cenobamate 200 mg/Day

Serious events: 4 serious events

Other events: 84 other events

Deaths: 0 deaths

Cenobamate 400 mg/Day

Serious events: 8 serious events

Other events: 100 other events

Deaths: 0 deaths

100mg/Day Open-Label Extension

Serious events: 21 serious events

Other events: 87 other events

Deaths: 1 deaths

200mg/Day Open-Label Extension

Serious events: 17 serious events

Other events: 80 other events

Deaths: 3 deaths

400mg/Day Open-Label Extension

Serious events: 21 serious events

Other events: 70 other events

Deaths: 3 deaths

Placebo Open-Label Extension

Serious events: 20 serious events

Other events: 80 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=108 participants at risk Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day n=108 participants at risk Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day n=110 participants at risk Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day n=111 participants at risk Subjects titrated to a target dose of 400 mg/day	100mg/Day Open-Label Extension n=95 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 100mg/day dose, with a target dose of 300 mg/day.	200mg/Day Open-Label Extension n=90 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 200mg/day dose, with a target dose of 300 mg/day.	400mg/Day Open-Label Extension n=70 participants at risk；n=80 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 400mg/day dose, with a target dose of 300 mg/day.	Placebo Open-Label Extension n=80 participants at risk；n=91 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a placebo dose, with a target dose of 300 mg/day.
Psychiatric disorders Psychogenic seizure	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Psychomotor retardation	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Psychotic disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Schizophrenia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Renal and urinary disorders Hydronephrosis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Renal and urinary disorders Renal impairment	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Epilepsy	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.5% 2/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Seizure cluster	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Balance disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Cerebellar haematoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Cerebral infarction	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Cerebrovascular accident	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Dysarthria	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Intracranial hypotension	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Neurological decompensation	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Paraesthesia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Partial seizures	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Partial seizures with secondary generalisation	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Postictal headache	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Sinus headache	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Anxiety disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Completed suicide	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Mental status change	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Lethargy	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Seizure	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.5% 2/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Ataxia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Dizziness	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.2% 3/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Nystagmus	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Hemiparesis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Somnolence	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Status epilepticus	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Fall	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Concussion	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Jaw fracture	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Laceration	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Limb injury	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Suicidal ideation	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Suicide attempt	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Abscess jaw	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Infectious colitis	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Investigations ALT increased	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Investigations AST increased	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Investigations Immunoglobulins decreased	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Chest pain	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Skin and subcutaneous tissue disorders DRESS	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Ear and labyrinth disorders Vertigo	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.3% 3/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Blood and lymphatic system disorders Anemia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Blood and lymphatic system disorders Anemia macrocytic	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Cardiac disorders Myocardial infarction	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.2% 2/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Cardiac disorders Bundle branch block left	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Cardiac disorders Cardiac arrest	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Cardiac disorders Cardiogenic shock	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Cardiac disorders Pericarditis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Eye disorders Diplopia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Eye disorders Vision blurred	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Entercolitis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Gastrointestinal ischaemia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Subileus	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Vomiting	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Medical device site reaction	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Pyrexia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Sudden unexplained death in epilepsy	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Hepatobiliary disorders Cholelithiasis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Hepatobiliary disorders Cholangitis acute	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Hepatobiliary disorders Cholecystitis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Pneumonia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.2% 2/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Pyelonephritis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Sepsis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.2% 2/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Appendicitis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Appendicitis perforated	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Cellulitis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Corona virus infection	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Enterocolitis bacterial	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Peritonsillar abscess	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Retroperitoneal abscess	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Shigella infection	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Urinary tract infection	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Contusion	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Cranicerebral injury	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Head injury	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Reproductive system and breast disorders Uterine polyp	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Vascular disorders Deep vein thrombosis	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/91 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.

Other adverse events

Other adverse events
Measure	Placebo n=108 participants at risk Subjects treated with identical appearing study drug.	Cenobamate 100 mg/Day n=108 participants at risk Subjects titrated to a target dose of 100 mg/day	Cenobamate 200 mg/Day n=110 participants at risk Subjects titrated to a target dose of 200 mg/day	Cenobamate 400 mg/Day n=111 participants at risk Subjects titrated to a target dose of 400 mg/day	100mg/Day Open-Label Extension n=95 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 100mg/day dose, with a target dose of 300 mg/day.	200mg/Day Open-Label Extension n=90 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 200mg/day dose, with a target dose of 300 mg/day.	400mg/Day Open-Label Extension n=70 participants at risk；n=80 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a 400mg/day dose, with a target dose of 300 mg/day.	Placebo Open-Label Extension n=80 participants at risk；n=91 participants at risk Subjects that consented to Open-Label Extension period of study. This includes subjects that began with a placebo dose, with a target dose of 300 mg/day.
Nervous system disorders Somnolence	8.3% 9/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	18.5% 20/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	20.9% 23/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	36.9% 41/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	25.3% 24/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	32.2% 29/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	37.1% 26/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	40.0% 32/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Dizziness	13.9% 15/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.6% 19/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	20.0% 22/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	33.3% 37/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	45.3% 43/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	32.2% 29/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	37.1% 26/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	37.5% 30/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Headache	5.6% 6/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.2% 11/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.9% 12/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.8% 12/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	22.1% 21/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.8% 16/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.9% 9/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	16.2% 13/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Balance disorder	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	9.0% 10/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.3% 3/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.8% 7/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Nystagmus	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.3% 7/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.3% 3/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.2% 9/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Ataxia	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.3% 7/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.4% 1/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.8% 7/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Dysarthria	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.3% 7/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.3% 6/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.3% 3/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Fatigue	8.3% 9/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.0% 13/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.3% 19/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	24.3% 27/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	18.9% 18/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	20.0% 18/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.4% 8/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	18.8% 15/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Gait disturbance	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.5% 6/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.1% 9/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	15.8% 15/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.9% 8/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.1% 12/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.5% 10/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Eye disorders Diplopia	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 8/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.0% 11/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	15.3% 17/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.9% 17/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	13.3% 12/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.9% 9/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	17.5% 14/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Constipation	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	9.0% 10/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.4% 1/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.8% 3/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Nausea	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.5% 7/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	9.0% 10/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.0% 8/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Vomiting	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.4% 6/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.6% 12/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.3% 3/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.8% 3/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Fall	5.6% 6/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.6% 11/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.1% 5/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	13.8% 11/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Upper respiratory tract infection	5.6% 6/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.6% 11/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	12.2% 11/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.4% 8/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	15.0% 12/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Musculoskeletal and connective tissue disorders Back pain	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.7% 4/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.4% 6/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	9.5% 9/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.8% 7/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.6% 6/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.0% 4/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Ear and labyrinth disorders Vertigo	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.4% 6/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.1% 5/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	16.2% 13/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Metabolism and nutrition disorders Decreased appetite	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.4% 6/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.2% 3/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.1% 5/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.8% 3/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Gastrointestinal disorders Diarrhea	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.5% 5/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.6% 6/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Nasopharyngitis	4.6% 5/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.5% 5/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.6% 11/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.7% 6/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	14.3% 10/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Laceration	4.6% 5/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Seizure	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.4% 8/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.2% 2/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.4% 8/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.8% 7/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Memory impairment	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.4% 8/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.0% 4/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Nervous system disorders Tremor	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.0% 4/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Urinary tract infection	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.2% 4/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.8% 7/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.1% 5/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	10.0% 8/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Sinusitis	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.2% 3/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.3% 3/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.5% 6/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Bronchitis	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	8.8% 7/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Influenza	3.7% 4/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.2% 4/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.2% 2/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Infections and infestations Respiratory tract infection	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
General disorders Pyrexia	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.5% 2/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Contusion	3.7% 4/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.3% 6/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.8% 3/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Injury, poisoning and procedural complications Ligament sprain	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Insomnia	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.8% 7/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.0% 4/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Psychiatric disorders Confusional state	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.7% 3/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.1% 2/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Eye disorders Vision blurred	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.6% 4/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.6% 5/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.4% 1/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	11.2% 9/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Musculoskeletal and connective tissue disorders Arthralgia	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	4.4% 4/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.4% 1/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.0% 4/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.8% 3/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.91% 1/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.7% 4/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 4/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	5.3% 5/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.2% 1/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Investigations Weight decreased	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.9% 2/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.4% 7/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.3% 3/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.1% 5/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	7.5% 6/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Skin and subcutaneous tissue disorders Rash	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.93% 1/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.8% 2/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.90% 1/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	3.3% 3/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	2.9% 2/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.
Immune system disorders Seasonal allergy	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/108 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/110 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/111 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/95 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	1.1% 1/90 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	0.00% 0/70 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.	6.2% 5/80 • 6.75 years Adverse events were collected for each subject for 18 weeks in the double-blind period, followed by a 2-week double-blind conversion period at the beginning of the open-label extension (OLE) phase for subjects that consented to the OLE. In addition, adverse events were collected for the full duration of the OLE, with a maximum drug exposure of 331 weeks. Adverse events and serious adverse events reported below are consistent of treatment-emergent events, unless otherwise stated.

Additional Information

Chief Medical Officer

SK Life Science

Phone: 201-421-3830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place