Trial Outcomes & Findings for A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection (NCT NCT01672983)

Last Updated: 2018-05-30

Results Overview

The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

24 weeks after last dose of study drug

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Overall Study STARTED	18	18	19	18	19	18
Overall Study Completed Study Drug	18	17	18	18	12	17
Overall Study COMPLETED	18	18	19	18	19	18
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 Participants Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 Participants Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Total n=110 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 15.06 • n=5 Participants	54.8 years STANDARD_DEVIATION 11.96 • n=7 Participants	61.9 years STANDARD_DEVIATION 8.14 • n=5 Participants	57.5 years STANDARD_DEVIATION 10.15 • n=4 Participants	62.5 years STANDARD_DEVIATION 8.34 • n=21 Participants	62.8 years STANDARD_DEVIATION 7.89 • n=8 Participants	59.2 years STANDARD_DEVIATION 10.84 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	10 Participants n=8 Participants	59 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	51 Participants n=8 Participants

PRIMARY outcome

Timeframe: 24 weeks after last dose of study drug

Population: Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	Arm 1 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 Participants Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 Participants Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)	100 percentage of participants Interval 81.47 to 100.0	88.9 percentage of participants Interval 65.29 to 98.62	100 percentage of participants Interval 82.35 to 100.0	100 percentage of participants Interval 81.47 to 100.0	57.9 percentage of participants Interval 33.5 to 79.75	72.2 percentage of participants Interval 46.52 to 90.31

PRIMARY outcome

Timeframe: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.

Population: Safety population: all participants who received at least 1 dose of study drug

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.

Outcome measures

Outcome measures
Measure	Arm 1 n=37 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=36 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Number of Participants With Adverse Events (AEs) Adverse Events	28 participants	31 participants	16 participants	15 participants	—	—
Number of Participants With Adverse Events (AEs) Serious Adverse Events	1 participants	2 participants	2 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: ITT population

The percentage of participants with SVR12 (plasma HCV RNA level \< LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

Outcome measures

Outcome measures
Measure	Arm 1 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 Participants Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 Participants Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)	100 percentage of participants Interval 81.47 to 100.0	88.9 percentage of participants Interval 65.29 to 98.62	100 percentage of participants Interval 82.35 to 100.0	100 percentage of participants Interval 81.47 to 100.0	57.9 percentage of participants Interval 33.5 to 79.75	72.2 percentage of participants Interval 46.52 to 90.31

SECONDARY outcome

Timeframe: 12 or 24 weeks after first dose of study drug

Population: ITT population

The percentage of participants with EOT response (plasma HCV RNA level \< LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.

Outcome measures

Outcome measures
Measure	Arm 1 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 Participants Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 Participants Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 Participants Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 Participants Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Percentage of Participants With End of Treatment (EOT) Response	100 percentage of participants Interval 81.47 to 100.0	100 percentage of participants Interval 81.47 to 100.0	100 percentage of participants Interval 82.35 to 100.0	100 percentage of participants Interval 81.47 to 100.0	63.2 percentage of participants Interval 38.36 to 83.71	83.3 percentage of participants Interval 58.58 to 96.42

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm 2

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 3

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Arm 4

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 5

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm 6

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 participants at risk Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 participants at risk Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Gastrointestinal disorders COLITIS ISCHAEMIC	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Hepatobiliary disorders AUTOIMMUNE HEPATITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Metabolism and nutrition disorders FLUID RETENTION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).

Other adverse events

Other adverse events
Measure	Arm 1 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 3 n=19 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 4 n=18 participants at risk Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Arm 5 n=19 participants at risk Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 6 n=18 participants at risk Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Blood and lymphatic system disorders HYPOCHROMIC ANAEMIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Blood and lymphatic system disorders NEUTROPHILIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Cardiac disorders PALPITATIONS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Cardiac disorders TACHYCARDIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Cardiac disorders VENTRICULAR EXTRASYSTOLES	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders ASTHENOPIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders BLEPHARITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders CHALAZION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders CONJUNCTIVITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders DIPLOPIA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders DRY EYE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders PUNCTATE KERATITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Eye disorders STRABISMUS	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders ABDOMINAL DISCOMFORT	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders ABDOMINAL PAIN	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders CONSTIPATION	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders DENTAL CARIES	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders DIARRHOEA	16.7% 3/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders DYSPEPSIA	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders ENTERITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders ENTEROCOLITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders GASTRITIS	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders GINGIVAL PAIN	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders GLOSSODYNIA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders NAUSEA	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders RADICULAR CYST	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders STOMATITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Gastrointestinal disorders VOMITING	16.7% 3/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders CHEST DISCOMFORT	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders FATIGUE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders MALAISE	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders OEDEMA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders OEDEMA PERIPHERAL	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders PAIN	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
General disorders PYREXIA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Hepatobiliary disorders BILIARY COLIC	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Immune system disorders SEASONAL ALLERGY	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations BRONCHITIS	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations CYSTITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations GASTROENTERITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations GASTROENTERITIS BACTERIAL	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations GASTROENTERITIS VIRAL	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations GINGIVITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations HELICOBACTER GASTRITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations INFLUENZA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations NASOPHARYNGITIS	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	33.3% 6/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	21.1% 4/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	50.0% 9/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	26.3% 5/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	38.9% 7/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations PERIODONTITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations PNEUMONIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications ANIMAL BITE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications ARTHROPOD STING	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications CONTUSION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD BILIRUBIN UNCONJUGATED INCREASED	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD CREATININE INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations BLOOD PRESSURE INCREASED	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations CREATININE RENAL CLEARANCE DECREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations HAEMOGLOBIN DECREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations PROTEIN URINE PRESENT	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations URINE LEUKOCYTE ESTERASE POSITIVE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Metabolism and nutrition disorders HYPOKALAEMIA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	16.7% 3/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders MYALGIA	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders MYOFASCIAL PAIN SYNDROME	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders AUTONOMIC NERVOUS SYSTEM IMBALANCE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders CERVICAL RADICULOPATHY	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders DIZZINESS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders HEAD DISCOMFORT	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders HEADACHE	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	15.8% 3/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	15.8% 3/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	27.8% 5/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders MIGRAINE	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Nervous system disorders SOMNOLENCE	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Psychiatric disorders DEPRESSION	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Psychiatric disorders DYSPHORIA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Psychiatric disorders INSOMNIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Renal and urinary disorders HAEMATURIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Renal and urinary disorders NOCTURIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Renal and urinary disorders PROTEINURIA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL DISCOMFORT	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders ALOPECIA AREATA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders CUTANEOUS LUPUS ERYTHEMATOSUS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders ECZEMA	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders HYPERHIDROSIS	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders PRURITUS	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders RASH	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	16.7% 3/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Vascular disorders HOT FLUSH	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	0.00% 0/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Vascular disorders HYPERTENSION	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	11.1% 2/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	10.5% 2/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.3% 1/19 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).	5.6% 1/18 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks). TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).

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AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

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Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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