Trial Outcomes & Findings for Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (NCT NCT02496767)

Last Updated: 2020-09-09

Results Overview

SVC was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, the patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to % predicted values (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics \[eg, height, age, sex\], based on Knudson 83 normative values).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

744 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-09-09

Participant Flow

Patients with familial or sporadic amyotrophic lateral sclerosis were enrolled at 79 sites in Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Spain, and the United States. The first patient was screened on 03 September 2015 and the last subject completed on 27 September 2017.

All enrolled patients began open-label tirasemtiv (250 mg) in a 2-week lead-in phase. Completed patients were randomized (3:2:2:2) to placebo or tirasemtiv (250, 375, or 500 mg) for 48 weeks of double-blind treatment. After which, patients on tirasemtiv were re-randomized (1:1) to placebo or tirasemtiv (current dose) for a 4-week withdrawal phase.

Participant milestones

Participant milestones
Measure	Open-label Lead-in: 250 mg Tirasemtiv Open-label tirasemiv (125 mg twice daily) for 2 weeks	Double-blind, Placebo-controlled: Group 1 - Placebo Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv Day 1 through Week 2: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Withdrawal: Placebo Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.	Double-blind, Withdrawal: Tirasemtiv to Placebo Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.	Double-blind, Withdrawal: Tirasemtiv Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
Open-label Lead-in Phase STARTED	744	0	0	0	0	0	0	0
Open-label Lead-in Phase COMPLETED	565	0	0	0	0	0	0	0
Open-label Lead-in Phase NOT COMPLETED	179	0	0	0	0	0	0	0
Double-blind, Placebo-controlled Phase STARTED	0	188	126	126	125	0	0	0
Double-blind, Placebo-controlled Phase COMPLETED	0	132	80	65	59	0	0	0
Double-blind, Placebo-controlled Phase NOT COMPLETED	0	56	46	61	66	0	0	0
Double-blind, Withdrawal Phase STARTED	0	0	0	0	0	132	103	101
Double-blind, Withdrawal Phase COMPLETED	0	0	0	0	0	126	99	96
Double-blind, Withdrawal Phase NOT COMPLETED	0	0	0	0	0	6	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Lead-in: 250 mg Tirasemtiv Open-label tirasemiv (125 mg twice daily) for 2 weeks	Double-blind, Placebo-controlled: Group 1 - Placebo Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv Day 1 through Week 2: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Withdrawal: Placebo Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.	Double-blind, Withdrawal: Tirasemtiv to Placebo Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.	Double-blind, Withdrawal: Tirasemtiv Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
Open-label Lead-in Phase Adverse Event	176	0	0	0	0	0	0	0
Open-label Lead-in Phase Protocol Violation	2	0	0	0	0	0	0	0
Open-label Lead-in Phase Lost to Follow-up	1	0	0	0	0	0	0	0
Double-blind, Placebo-controlled Phase Adverse Event	0	13	23	43	43	0	0	0
Double-blind, Placebo-controlled Phase Progressive disease	0	13	9	8	14	0	0	0
Double-blind, Placebo-controlled Phase Death	0	10	6	2	4	0	0	0
Double-blind, Placebo-controlled Phase Various	0	9	4	5	2	0	0	0
Double-blind, Placebo-controlled Phase Withdrawal by Subject	0	4	3	1	2	0	0	0
Double-blind, Placebo-controlled Phase Physician Decision	0	4	1	0	0	0	0	0
Double-blind, Placebo-controlled Phase Lost to Follow-up	0	2	0	2	1	0	0	0
Double-blind, Placebo-controlled Phase Protocol Violation	0	1	0	0	0	0	0	0
Double-blind, Withdrawal Phase Progressive disease	0	0	0	0	0	4	0	1
Double-blind, Withdrawal Phase Adverse Event	0	0	0	0	0	1	2	1
Double-blind, Withdrawal Phase Death	0	0	0	0	0	0	1	2
Double-blind, Withdrawal Phase Withdrawal by Subject	0	0	0	0	0	1	1	1

Baseline Characteristics

Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet (125 mg) of tirasemtiv and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Total n=561 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 10.63 • n=5 Participants	57.1 years STANDARD_DEVIATION 10.20 • n=7 Participants	57.4 years STANDARD_DEVIATION 9.09 • n=5 Participants	56.0 years STANDARD_DEVIATION 10.81 • n=4 Participants	56.5 years STANDARD_DEVIATION 10.24 • n=21 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	30 Participants n=7 Participants	42 Participants n=5 Participants	38 Participants n=4 Participants	175 Participants n=21 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	96 Participants n=7 Participants	83 Participants n=5 Participants	84 Participants n=4 Participants	386 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	181 Participants n=5 Participants	123 Participants n=7 Participants	120 Participants n=5 Participants	117 Participants n=4 Participants	541 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Riluzole use at baseline	141 Participants n=5 Participants	95 Participants n=7 Participants	94 Participants n=5 Participants	92 Participants n=4 Participants	422 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The data presented are for the Full Analysis Set, comprised of patients who received at least 1 dose of study drug during the randomized double-blind, placebo-controlled phase and had at least 1 post-randomization efficacy assessment.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Change From Baseline to Week 24 of the Double-blind, Placebo-controlled Phase in Percent Predicted Slow Vital Capacity (SVC)	-14.354 % predicted Standard Error 1.2270	-12.648 % predicted Standard Error 1.5165	-13.742 % predicted Standard Error 1.6076	-13.927 % predicted Standard Error 1.7213

SECONDARY outcome

Timeframe: 48 weeks

Population: The data provided are for the Full Analysis Set, comprised of patients who received at least 1 dose of study drug during the randomized double-blind, placebo-controlled phase and had at least 1 post-randomization efficacy assessment.

The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 4 domains: bulbar functions, fine motor tasks, gross motor tasks, and respiratory function. Respiratory function consists of 3 of the 12 questions, which assess dyspnea, orthopnea, and respiratory insufficiency. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The sum of the response to these 3 questions represents the respiratory domain score. The respiratory domain score ranges from 0 to 12, with higher scores reflecting more normal function and lower scores reflecting more impaired function.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Change From Baseline in the ALSFRS-R Respiratory Domain Score at the End of 48 Weeks of Double-blind, Placebo-controlled Treatment	-2.26 units on a scale Standard Error 0.258	-1.95 units on a scale Standard Error 0.320	-2.41 units on a scale Standard Error 0.340	-2.59 units on a scale Standard Error 0.355

SECONDARY outcome

Timeframe: 48 weeks

A hand-held dynomometer, with a scale of 0 to 300 pounds, was used to measure muscle strength and handgrip strength (bilateral); the muscle groups tested were: elbow flexion (bilateral), wrist extension (bilateral), knee extension (bilateral), and ankle dorsiflexion (bilateral). The muscle strength mega-score was calculated as the average of responses to all tested muscles as well as handgrip strength. The slope of muscle strength mega-score was the change over time (48 weeks) and analyzed using a mixed model that assumed a random slope effect. For this endpoint, negative values indicate a decline in muscle strength over time.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Slope of Mega-score of Muscle Strength During the 48 Weeks of Double-blind, Placebo-controlled Treatment	-0.1501 pounds/day Interval -0.1729 to -0.1272	-0.1512 pounds/day Interval -0.1794 to -0.123	-0.1434 pounds/day Interval -0.1742 to -0.1126	-0.1413 pounds/day Interval -0.173 to -0.1095

SECONDARY outcome

Timeframe: 48 weeks

This endpoint evaluated the time to occurrence of a decline in percent predicted SVC (as measured by spirometry) of ≥ 20 percentage points, or the onset of respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥ 22 hours per day for ≥10 consecutive days), or death, whichever was first, during the 48-week double-blind, placebo-controlled treatment phase. Note: The median time to a ≥ 20% decline in percent predicted SVC, onset of respiratory insufficiency, or death was 302 days for the placebo group and 359, 334, and 337 days for the 250 mg, 375 mg, and 500 mg tirasemtiv groups, respectively. The data presented for this endpoint are the number and percent of patients who met the endpoint.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Time to the First Occurrence of a Decline From Baseline in Percent Predicted SVC ≥ 20 Percentage Points or the Onset of Respiratory Insufficiency or Death All 48 Weeks of Double-blind, Placebo-controlled Treatment	98 Participants	58 Participants	58 Participants	57 Participants

SECONDARY outcome

Timeframe: 48 weeks

This endpoint evaluated the time to occurrence of a decline in SVC (as measured by spirometry) to ≤ 50% predicted, or the onset of respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥ 22 hours per day for ≥10 consecutive days), or death, whichever was first, during the 48-week double-blind, placebo-controlled treatment phase. Note: The median time to a decline in SVC to ≤ 50% predicted, onset of respiratory insufficiency, or death was not estimable for the placebo group or the 375 mg tirasemtiv group. The median time was estimated as 363 and 351 days for the 250 mg and 500 mg tirasemtiv groups, respectively. The data presented for this endpoint are the number and percent of patients who met the endpoint.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Time to the First Occurrence of a Decline in SVC to ≤ 50% Predicted, or the Onset of Respiratory Insufficiency, or Death During the 48 Weeks of Double-blind, Placebo-controlled Treatment	57 Participants	39 Participants	30 Participants	32 Participants

SECONDARY outcome

Timeframe: 48 weeks

The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Change From Baseline in the ALSFRS-R Total Score to the End of 48 Weeks of the Double-blind, Placebo-controlled Treatment	-11.39 units on a scale Standard Error 0.695	-11.39 units on a scale Standard Error 0.859	-12.19 units on a scale Standard Error 0.903	-11.99 units on a scale Standard Error 0.937

SECONDARY outcome

Timeframe: 48 weeks

This endpoint evaluated the time to occurrence of mechanical ventilatory assistance (defined as invasive or non-invasive ventilation for at least 2 hours over a 24-hour period for at least 5 consecutive days) or death, whichever was first, during the 48-week double-blind, placebo-controlled treatment phase. Note: The median time to first use of mechanical ventilatory assistance or death was not estimable for all but the 375 mg tirasemtiv group (with a value of 367 days). As such the number and percent of patients who met the endpoint (ie, had mechanical ventilatory assistance or died) are presented.

Outcome measures

Outcome measures
Measure	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 Participants Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 Participants Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=125 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=122 Participants Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM
Time to the First Use of Mechanical Ventilatory Assistance or Death During All 48 Weeks of Double-blind, Placebo-controlled Treatment	60 Participants	31 Participants	37 Participants	33 Participants

Adverse Events

Open-label Lead-in: 250 mg Tirasemtiv

Serious events: 11 serious events

Other events: 640 other events

Deaths: 1 deaths

Double-blind, Placebo-controlled: Group 1 - Placebo

Serious events: 53 serious events

Other events: 182 other events

Deaths: 17 deaths

Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv

Serious events: 30 serious events

Other events: 125 other events

Deaths: 8 deaths

Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv

Serious events: 30 serious events

Other events: 125 other events

Deaths: 10 deaths

Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv

Serious events: 32 serious events

Other events: 125 other events

Deaths: 8 deaths

Double-blind, Withdrawal: Placebo

Serious events: 15 serious events

Other events: 123 other events

Deaths: 5 deaths

Double-blind, Withdrawal: Tirasemtiv to Placebo

Serious events: 15 serious events

Other events: 100 other events

Deaths: 4 deaths

Double-blind, Withdrawal: Tirasemtiv

Serious events: 11 serious events

Other events: 95 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Open-label Lead-in: 250 mg Tirasemtiv n=744 participants at risk Open-label tirasemiv (125 mg twice daily) for 2 weeks	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 participants at risk Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 participants at risk Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=126 participants at risk Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=125 participants at risk Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Withdrawal: Placebo n=132 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.	Double-blind, Withdrawal: Tirasemtiv to Placebo n=103 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.	Double-blind, Withdrawal: Tirasemtiv n=101 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Atrial tachycardia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Cardiac arrest	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Cor pulmonale acute	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Stress cardiomyopathy	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Supraventricular tachycardia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.1% 2/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Tachycardia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Cardiac disorders Ventricular fibrillation	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Constipation	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Diarrhoea	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Dysphagia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 9/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Ileus	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Intestinal polyp	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Nausea	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Pancreatitis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Vomiting	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Asthenia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Death	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Device dislocation	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Device malfunction	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Euthanasia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Sudden death	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Hepatobiliary disorders Cholecystitis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Immune system disorders Drug hypersensitivity	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Appendicitis	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Bacteraemia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Bronchitis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.1% 2/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Bronchitis bacterial	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Bronchopneumonia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Cellulitis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.1% 2/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Device related sepsis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Klebsiella bacteraemia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Lobar pneumonia	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Lower respiratory tract infection	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Otitis externa	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Otitis media acute	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Pneumonia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Genital neoplasm malignant female	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular cancer metastatic	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Basal ganglia stroke	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Cerebellar infarction	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Clonus	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Ischaemic stroke	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Loss of consciousness	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Muscle spasticity	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Somnolence	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Syncope	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Thalamic infarction	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Toxic encephalopathy	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Transient ischaemic attack	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Tremor	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Abnormal behaviour	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Adjustment disorder with anxiety	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Completed suicide	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Hallucination, auditory	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Hallucination, visual	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Mania	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Mental status changes	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Panic attack	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Renal and urinary disorders Cystitis interstitial	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Renal and urinary disorders Nephrolithiasis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Renal and urinary disorders Urinary retention	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.0% 2/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 3/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.3% 8/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Vascular disorders Deep vein thrombosis	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Respiratory tract infection	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Serratia bacteraemia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Tracheobronchitis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Urosepsis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Traumatic fracture	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Liver function test abnormal	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Oxygen saturation decreased	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Pulmonary function test decreased	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 3/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Weight decreased	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.1% 2/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Metabolism and nutrition disorders Dehydration	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.53% 1/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Metabolism and nutrition disorders Malnutrition	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.80% 1/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.

Other adverse events

Other adverse events
Measure	Open-label Lead-in: 250 mg Tirasemtiv n=744 participants at risk Open-label tirasemiv (125 mg twice daily) for 2 weeks	Double-blind, Placebo-controlled: Group 1 - Placebo n=188 participants at risk Day 1 through Week 48: 2 placebo tablets twice daily	Double-blind, Placebo-controlled: Group 2 - 250 mg Tirasemtiv n=126 participants at risk Day 1 through Week 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM	Double-blind, Placebo-controlled: Group 3 - 375 mg Tirasemtiv n=126 participants at risk Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 through 48: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Placebo-controlled: Group 4 - 500 mg Tirasemtiv n=125 participants at risk Day 1 through Week 2: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the PM; Weeks 3 and 4: 1 tablet of tirasemtiv (125 mg) and 1 tablet of matching placebo in the AM and 2 tablets of tirasemtiv (250 mg) in the PM; Weeks 5 through 48: 2 tablets of tirasemtiv (250 mg) in the AM and 2 tablets of tirasemtiv (250 mg) in the PM	Double-blind, Withdrawal: Placebo n=132 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, patients in the placebo group continued placebo for an additional 4 weeks.	Double-blind, Withdrawal: Tirasemtiv to Placebo n=103 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to placebo treatment for 4 weeks.	Double-blind, Withdrawal: Tirasemtiv n=101 participants at risk Following the 48-week double-blind, placebo-controlled phase of the study, approximately half the patients in a tirasemtiv group were re-randomized to remain on tirasemtiv treatment (at the same dose received at the end of the double-blind, placebo-controlled phase) for 4 weeks.
Gastrointestinal disorders Abdominal distension	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.1% 2/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Constipation	2.8% 21/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	21.3% 40/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.0% 24/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.7% 21/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	21.6% 27/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.9% 17/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.6% 15/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.9% 13/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Diarrhoea	3.2% 24/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.1% 19/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 10/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.2% 9/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.8% 5/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.0% 2/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Dry mouth	1.3% 10/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.4% 14/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.3% 7/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 8/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Dysphagia	1.2% 9/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.6% 33/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	22.2% 28/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.5% 22/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.8% 16/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.7% 22/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.5% 17/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.8% 17/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.67% 5/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.3% 8/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 6/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Nausea	14.5% 108/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.0% 30/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.9% 20/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	30.2% 38/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	20.8% 26/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 9/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 7/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 6/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Gastrointestinal disorders Salivary hypersecretion	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.1% 19/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.1% 14/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.6% 14/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.9% 11/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Asthenia	5.6% 42/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.7% 22/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.5% 22/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.6% 22/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.1% 12/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.7% 10/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.9% 9/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Fatigue	27.4% 204/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	32.4% 61/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	34.1% 43/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	42.9% 54/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	40.0% 50/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	24.2% 32/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	31.1% 32/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	22.8% 23/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Gait disturbance	2.6% 19/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 13/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 10/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.2% 9/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.1% 12/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 7/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.9% 11/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Oedema peripheral	1.1% 8/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.1% 19/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.0% 10/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.6% 10/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.7% 10/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 7/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
General disorders Peripheral swelling	0.27% 2/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 9/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 4/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.8% 6/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Nasopharyngitis	1.7% 13/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.0% 30/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.1% 19/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.9% 20/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 12/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.3% 7/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Upper respiratory tract infection	0.54% 4/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.0% 17/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.2% 9/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 4/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Infections and infestations Urinary tract infection	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.3% 8/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.2% 9/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.9% 2/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Contusion	2.4% 18/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.1% 34/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.9% 15/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.3% 23/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.4% 18/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.8% 5/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.8% 6/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Laceration	0.27% 2/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 13/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.3% 13/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 12/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.8% 5/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.0% 2/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Ligament sprain	0.54% 4/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 12/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Post-traumatic pain	1.1% 8/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.8% 26/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.7% 16/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.1% 14/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 8/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.5% 6/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Skin abrasion	0.94% 7/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.8% 24/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.5% 22/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 12/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.1% 8/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Traumatic fracture	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 12/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 4/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.9% 2/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Weight decreased	0.94% 7/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	21.3% 40/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	32.5% 41/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	32.5% 41/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	22.4% 28/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.7% 26/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	30.1% 31/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	34.7% 35/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Metabolism and nutrition disorders Decreased appetite	6.0% 45/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.1% 19/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.7% 16/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.1% 19/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.8% 21/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.6% 10/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 6/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Arthralgia	0.54% 4/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.4% 14/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.1% 8/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 6/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Back pain	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.0% 15/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.7% 11/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.2% 9/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.1% 8/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 7/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 8/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Muscle spasms	4.4% 33/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.1% 34/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.5% 17/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.0% 24/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.6% 17/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.7% 22/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.5% 18/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.8% 17/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Muscular weakness	7.3% 54/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	30.9% 58/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	41.3% 52/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	33.3% 42/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	27.2% 34/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	36.4% 48/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	43.7% 45/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	41.6% 42/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.67% 5/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.7% 22/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.6% 10/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.7% 10/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 6/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Myalgia	0.81% 6/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 12/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.5% 6/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Neck pain	0.27% 2/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.3% 10/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.3% 7/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 14/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.0% 17/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.1% 9/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.8% 11/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.3% 11/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 7/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 8/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Balance disorder	2.6% 19/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.8% 6/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 4/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Dizziness	48.5% 361/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	23.9% 45/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	37.3% 47/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	43.7% 55/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	44.8% 56/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.3% 11/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	20.4% 21/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.9% 15/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Dysarthria	4.0% 30/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 18/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.9% 15/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 12/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.8% 13/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.7% 11/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.9% 10/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Headache	4.8% 36/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.9% 28/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.3% 13/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.7% 21/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.2% 19/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.7% 12/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 7/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Muscle contractions involuntary	1.5% 11/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 9/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.9% 15/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.6% 12/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.8% 5/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 7/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Muscle spasticity	1.5% 11/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.9% 10/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 4/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.8% 7/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 7/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Somnolence	12.1% 90/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	7.4% 14/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.1% 19/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	15.1% 19/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.4% 18/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.9% 10/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Tremor	3.0% 22/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.1% 4/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.3% 13/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.8% 11/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.8% 5/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Affect lability	1.1% 8/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 6/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.0% 5/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.1% 8/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.9% 2/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Anxiety	2.0% 15/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.1% 19/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.1% 14/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.3% 13/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.2% 24/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.8% 13/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.6% 15/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.9% 10/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Depression	2.8% 21/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	11.7% 22/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.0% 24/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.4% 23/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.6% 14/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.7% 9/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.9% 14/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Psychiatric disorders Insomnia	4.2% 31/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.3% 25/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.3% 23/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	19.8% 25/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	24.0% 30/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.4% 19/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.4% 19/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.8% 18/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Cough	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.8% 26/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.7% 16/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.1% 12/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.9% 7/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.5% 26/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	18.6% 35/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	13.5% 17/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	17.5% 22/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	14.4% 18/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	16.7% 22/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.6% 13/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	12.9% 13/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.54% 4/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.9% 11/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	8.7% 11/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.1% 8/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.0% 5/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.13% 1/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 12/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.5% 6/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.0% 2/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Skin and subcutaneous tissue disorders Rash	1.1% 8/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 9/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	9.5% 12/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 8/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.9% 5/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 3/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Nervous system disorders Parathesia	0.81% 6/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 3/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.79% 1/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.4% 8/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.76% 1/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.2% 9/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 6/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	4.8% 6/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Injury, poisoning and procedural complications Head injury	0.40% 3/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.7% 5/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	6.3% 8/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.97% 1/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Investigations Blood creatine phosphokinase increased	0.00% 0/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 3/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.6% 2/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	1.5% 2/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.9% 3/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.0% 2/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Skin and subcutaneous tissue disorders Pruritis	1.3% 10/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.7% 5/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.9% 4/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.99% 1/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.54% 4/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 6/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.4% 3/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.0% 4/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.8% 6/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.
Ear and labyrinth disorders Vertigo	2.6% 19/744 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.7% 7/188 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	10.3% 13/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	5.6% 7/126 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	3.2% 4/125 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	2.3% 3/132 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/103 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.	0.00% 0/101 • AEs were collected from the first dose of open-label study drug through 28 days after the last dose of study drug. An AE was treatment-emergent if it started or worsened in severity after the first dose of study drug (in either the open-label \[OL\] or double-blind \[DB\] phases). The onset date of a TEAE in the OL phase that continued uninterrupted for ≥96 hours in the DB placebo-controlled phase was the date of the first dose of DB study drug. For patients randomized in the DB withdrawal phase, the onset date was on or before the last dose of study drug in the DB placebo-controlled phase.

Additional Information

MD Cytokinetics

Cytokinetics, Inc.

Phone: 650-624-2929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place