Trial Outcomes & Findings for An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis (NCT NCT00383188)

Last Updated: 2021-08-20

Results Overview

ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

305 participants

Primary outcome timeframe

Week 12

Results posted on

2021-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	PH-797804, 0.5 mg Participants received PH-797804, 0.5 milligram (mg) capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH79804, 3 mg Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Overall Study STARTED	69	74	44	40	75
Overall Study COMPLETED	52	63	31	28	52
Overall Study NOT COMPLETED	17	11	13	12	23

Reasons for withdrawal

Reasons for withdrawal
Measure	PH-797804, 0.5 mg Participants received PH-797804, 0.5 milligram (mg) capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH79804, 3 mg Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Overall Study Adverse Event	4	7	9	8	8
Overall Study Lack of Efficacy	9	3	3	2	6
Overall Study Other	3	1	0	2	6
Overall Study No longer willing to participate	1	0	1	0	2
Overall Study Lost to Follow-up	0	0	0	0	1

Baseline Characteristics

An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH79804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Total n=302 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	60 Participants n=7 Participants	39 Participants n=5 Participants	36 Participants n=4 Participants	65 Participants n=21 Participants	259 Participants n=8 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	43 Participants n=8 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	62 Participants n=7 Participants	38 Participants n=5 Participants	35 Participants n=4 Participants	60 Participants n=21 Participants	256 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants	46 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. Missing values were imputed using last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=74 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12	39.13 percentage of participants	41.89 percentage of participants	40.91 percentage of participants	40.00 percentage of participants	31.08 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 16

Population: FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. Missing values were imputed using LOCF except for Week 16.

ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/L. PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assessed arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 Week 1	14.93 percentage of participants	21.13 percentage of participants	27.91 percentage of participants	15.38 percentage of participants	13.89 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 Week 2	30.43 percentage of participants	29.73 percentage of participants	40.91 percentage of participants	40.00 percentage of participants	24.32 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 Week 4	31.88 percentage of participants	41.89 percentage of participants	43.18 percentage of participants	47.50 percentage of participants	27.03 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 Week 8	28.99 percentage of participants	45.95 percentage of participants	40.91 percentage of participants	47.50 percentage of participants	31.08 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16 Week 16	38.71 percentage of participants	42.86 percentage of participants	44.74 percentage of participants	28.95 percentage of participants	41.43 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12 and 16

ACR50 responders: participants with \>= 50% improvement in tender and swollen 28-joint counts from baseline and \>= 50% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and C-reactive protein (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 8	4.35 percentage of participants	17.57 percentage of participants	20.45 percentage of participants	15.00 percentage of participants	13.51 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 1	1.49 percentage of participants	1.41 percentage of participants	4.65 percentage of participants	5.13 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 2	5.80 percentage of participants	9.46 percentage of participants	11.36 percentage of participants	12.50 percentage of participants	1.35 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 4	2.90 percentage of participants	13.51 percentage of participants	18.18 percentage of participants	17.50 percentage of participants	5.41 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 12	17.39 percentage of participants	21.62 percentage of participants	20.45 percentage of participants	17.50 percentage of participants	12.16 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 16	19.35 percentage of participants	18.57 percentage of participants	15.79 percentage of participants	5.26 percentage of participants	21.43 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12 and 16

ACR70 responders: participants with \>=70% improvement in tender and swollen 28-joint counts from baseline and \>= 70% improvement in at least 3 of the 5 measures: PGA, physician global assessment, Pain-VAS, HAQ-DI and CRP (in mg/L). PGA: participant assessed overall disease activity on VAS, score: 0 (no arthritis) to 100 (extreme arthritis), higher score=more arthritis. Physician global assessment: physician judged participant's overall disease activity on VAS, score: 0 (no arthritis) to 100 mm VAS (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 1	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 2	0.00 percentage of participants	0.00 percentage of participants	2.27 percentage of participants	2.50 percentage of participants	0.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 4	1.45 percentage of participants	0.00 percentage of participants	6.82 percentage of participants	5.00 percentage of participants	1.35 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 8	1.45 percentage of participants	4.05 percentage of participants	11.36 percentage of participants	10.00 percentage of participants	4.05 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 12	7.25 percentage of participants	8.11 percentage of participants	9.09 percentage of participants	7.50 percentage of participants	5.41 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16 Week 16	4.84 percentage of participants	7.14 percentage of participants	2.63 percentage of participants	2.63 percentage of participants	10.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12 and 16

A total of 28 tender/painful joints were assessed for tenderness or pain. The 28 joints included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees. Artificial joints were not assessed.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-2.486 Joint count Standard Error 0.751	-3.409 Joint count Standard Error 0.722	-4.285 Joint count Standard Error 0.944	-2.948 Joint count Standard Error 0.981	-2.098 Joint count Standard Error 0.730
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-4.291 Joint count Standard Error 0.746	-4.334 Joint count Standard Error 0.714	-5.751 Joint count Standard Error 0.938	-4.348 Joint count Standard Error 0.975	-3.003 Joint count Standard Error 0.724
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-5.132 Joint count Standard Error 0.746	-4.982 Joint count Standard Error 0.714	-5.774 Joint count Standard Error 0.938	-4.723 Joint count Standard Error 0.975	-3.368 Joint count Standard Error 0.724
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-4.827 Joint count Standard Error 0.746	-6.090 Joint count Standard Error 0.714	-5.797 Joint count Standard Error 0.938	-5.223 Joint count Standard Error 0.975	-4.069 Joint count Standard Error 0.723
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-5.842 Joint count Standard Error 0.746	-5.996 Joint count Standard Error 0.714	-6.146 Joint count Standard Error 0.938	-5.673 Joint count Standard Error 0.975	-3.762 Joint count Standard Error 0.722
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-5.505 Joint count Standard Error 0.776	-4.982 Joint count Standard Error 0.725	-5.560 Joint count Standard Error 0.977	-5.069 Joint count Standard Error 1.011	-5.254 Joint count Standard Error 0.738

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12 and 16

A total of 28 swollen joints were assessed. The 28 joints included: shoulders, elbows, wrists, MCP joints, PIP joints, and knees. Artificial joints were not assessed.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-2.341 Joint count Standard Error 0.650	-2.738 Joint count Standard Error 0.625	-3.224 Joint count Standard Error 0.816	-2.328 Joint count Standard Error 0.849	-1.654 Joint count Standard Error 0.633
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-3.847 Joint count Standard Error 0.645	-3.409 Joint count Standard Error 0.618	-4.041 Joint count Standard Error 0.811	-3.187 Joint count Standard Error 0.843	-2.382 Joint count Standard Error 0.629
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-4.368 Joint count Standard Error 0.645	-4.369 Joint count Standard Error 0.618	-4.599 Joint count Standard Error 0.811	-3.262 Joint count Standard Error 0.843	-2.769 Joint count Standard Error 0.628
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-4.412 Joint count Standard Error 0.645	-4.504 Joint count Standard Error 0.618	-4.134 Joint count Standard Error 0.811	-3.937 Joint count Standard Error 0.843	-3.236 Joint count Standard Error 0.628
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-4.992 Joint count Standard Error 0.645	-4.477 Joint count Standard Error 0.618	-4.227 Joint count Standard Error 0.811	-3.587 Joint count Standard Error 0.843	-3.391 Joint count Standard Error 0.627
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-4.300 Joint count Standard Error 0.669	-4.168 Joint count Standard Error 0.626	-4.138 Joint count Standard Error 0.842	-4.166 Joint count Standard Error 0.872	-4.676 Joint count Standard Error 0.640

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12 and 16

Participants self-assessed the severity of arthritis pain using a 100 mm VAS between 0 mm (no pain) and 100 mm (most severe pain), where higher scores indicate higher degree of pain intensity.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-16.50 Millimeter (mm) Standard Error 2.977	-19.52 Millimeter (mm) Standard Error 2.842	-23.16 Millimeter (mm) Standard Error 3.746	-16.93 Millimeter (mm) Standard Error 3.889	-9.058 Millimeter (mm) Standard Error 2.884
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-13.82 Millimeter (mm) Standard Error 2.977	-21.79 Millimeter (mm) Standard Error 2.842	-19.95 Millimeter (mm) Standard Error 3.746	-13.76 Millimeter (mm) Standard Error 3.889	-11.85 Millimeter (mm) Standard Error 2.884
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-10.86 Millimeter (mm) Standard Error 2.977	-23.37 Millimeter (mm) Standard Error 2.842	-20.65 Millimeter (mm) Standard Error 3.746	-18.68 Millimeter (mm) Standard Error 3.889	-12.72 Millimeter (mm) Standard Error 2.883
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-15.06 Millimeter (mm) Standard Error 2.977	-21.37 Millimeter (mm) Standard Error 2.842	-19.18 Millimeter (mm) Standard Error 3.746	-20.38 Millimeter (mm) Standard Error 3.889	-10.30 Millimeter (mm) Standard Error 2.880
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-14.20 Millimeter (mm) Standard Error 3.104	-20.88 Millimeter (mm) Standard Error 2.888	-15.19 Millimeter (mm) Standard Error 3.913	-14.70 Millimeter (mm) Standard Error 4.047	-19.09 Millimeter (mm) Standard Error 2.949
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-9.289 Millimeter (mm) Standard Error 3.012	-16.67 Millimeter (mm) Standard Error 2.876	-19.22 Millimeter (mm) Standard Error 3.796	-17.62 Millimeter (mm) Standard Error 3.919	-6.486 Millimeter (mm) Standard Error 2.907

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16

Participants responded to the question "Considering all the ways your arthritis affects you, how are you feeling today?" was recorded using a 0-100 mm VAS where 0 mm (very well) and 100 mm (very poor). Higher scores indicated worse condition.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 1	-8.160 Millimeter (mm) Standard Error 2.911	-19.61 Millimeter (mm) Standard Error 2.777	-16.70 Millimeter (mm) Standard Error 3.633	-12.53 Millimeter (mm) Standard Error 3.782	-5.164 Millimeter (mm) Standard Error 2.812
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 2	-13.66 Millimeter (mm) Standard Error 2.875	-18.02 Millimeter (mm) Standard Error 2.743	-20.32 Millimeter (mm) Standard Error 3.608	-14.99 Millimeter (mm) Standard Error 3.753	-9.667 Millimeter (mm) Standard Error 2.788
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 4	-13.21 Millimeter (mm) Standard Error 2.875	-20.47 Millimeter (mm) Standard Error 2.743	-19.53 Millimeter (mm) Standard Error 3.608	-12.74 Millimeter (mm) Standard Error 3.753	-10.24 Millimeter (mm) Standard Error 2.787
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 8	-9.062 Millimeter (mm) Standard Error 2.875	-21.86 Millimeter (mm) Standard Error 2.743	-18.79 Millimeter (mm) Standard Error 3.608	-18.09 Millimeter (mm) Standard Error 3.753	-12.84 Millimeter (mm) Standard Error 2.786
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 12	-15.54 Millimeter (mm) Standard Error 2.875	-21.77 Millimeter (mm) Standard Error 2.743	-20.02 Millimeter (mm) Standard Error 3.608	-18.54 Millimeter (mm) Standard Error 3.753	-11.50 Millimeter (mm) Standard Error 2.784
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16 Week 16	-13.91 Millimeter (mm) Standard Error 3.004	-21.82 Millimeter (mm) Standard Error 2.789	-13.29 Millimeter (mm) Standard Error 3.776	-13.26 Millimeter (mm) Standard Error 3.911	-19.84 Millimeter (mm) Standard Error 2.854

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16

Physician assessed the overall impact of arthritis on the participants' daily life based on the disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS between 0 mm (very good) and 100 mm (very poor). Higher scores indicating worse condition of arthritis.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-6.612 Millimeter (mm) Standard Error 2.451	-10.83 Millimeter (mm) Standard Error 2.343	-14.92 Millimeter (mm) Standard Error 3.053	-8.898 Millimeter (mm) Standard Error 3.183	-5.203 Millimeter (mm) Standard Error 2.364
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-15.87 Millimeter (mm) Standard Error 2.430	-17.79 Millimeter (mm) Standard Error 2.324	-20.43 Millimeter (mm) Standard Error 3.032	-16.15 Millimeter (mm) Standard Error 3.159	-10.68 Millimeter (mm) Standard Error 2.343
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-13.91 Millimeter (mm) Standard Error 2.430	-20.41 Millimeter (mm) Standard Error 2.324	-22.40 Millimeter (mm) Standard Error 3.032	-16.23 Millimeter (mm) Standard Error 3.159	-13.51 Millimeter (mm) Standard Error 2.343
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-14.44 Millimeter (mm) Standard Error 2.430	-24.15 Millimeter (mm) Standard Error 2.324	-22.59 Millimeter (mm) Standard Error 3.032	-21.38 Millimeter (mm) Standard Error 3.159	-13.05 Millimeter (mm) Standard Error 2.342
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-16.90 Millimeter (mm) Standard Error 2.430	-23.05 Millimeter (mm) Standard Error 2.324	-22.61 Millimeter (mm) Standard Error 3.032	-18.80 Millimeter (mm) Standard Error 3.159	-13.27 Millimeter (mm) Standard Error 2.339
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-19.97 Millimeter (mm) Standard Error 2.555	-18.44 Millimeter (mm) Standard Error 2.364	-19.21 Millimeter (mm) Standard Error 3.173	-18.56 Millimeter (mm) Standard Error 3.291	-19.85 Millimeter (mm) Standard Error 2.409

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16

C-reactive protein is a biochemical measure of inflammation and disease activity.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 16	1.060 milligram per liter (mg/L) Standard Error 3.426	-1.844 milligram per liter (mg/L) Standard Error 3.093	-5.559 milligram per liter (mg/L) Standard Error 4.109	-4.313 milligram per liter (mg/L) Standard Error 4.301	-7.201 milligram per liter (mg/L) Standard Error 3.234
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-4.785 milligram per liter (mg/L) Standard Error 3.285	-10.92 milligram per liter (mg/L) Standard Error 3.094	-12.87 milligram per liter (mg/L) Standard Error 3.953	-12.06 milligram per liter (mg/L) Standard Error 4.244	4.198 milligram per liter (mg/L) Standard Error 3.124
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-1.077 milligram per liter (mg/L) Standard Error 3.226	-6.582 milligram per liter (mg/L) Standard Error 3.024	-9.926 milligram per liter (mg/L) Standard Error 3.880	-6.835 milligram per liter (mg/L) Standard Error 4.077	2.764 milligram per liter (mg/L) Standard Error 3.038
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 4	3.492 milligram per liter (mg/L) Standard Error 3.226	0.324 milligram per liter (mg/L) Standard Error 3.024	-3.642 milligram per liter (mg/L) Standard Error 3.880	4.182 milligram per liter (mg/L) Standard Error 4.077	2.688 milligram per liter (mg/L) Standard Error 3.038
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 8	7.190 milligram per liter (mg/L) Standard Error 3.226	3.804 milligram per liter (mg/L) Standard Error 3.024	-1.249 milligram per liter (mg/L) Standard Error 3.880	6.727 milligram per liter (mg/L) Standard Error 4.077	3.899 milligram per liter (mg/L) Standard Error 3.038
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16 Week 12	5.468 milligram per liter (mg/L) Standard Error 3.226	0.104 milligram per liter (mg/L) Standard Error 3.024	2.970 milligram per liter (mg/L) Standard Error 3.880	11.585 milligram per liter (mg/L) Standard Error 4.077	2.361 milligram per liter (mg/L) Standard Error 3.038

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 4, 8, 12 and 16

DAS28-4 (CRP) was calculated from 28-tender joint count and 28-swollen joint count, C-reactive protein (mg/L) and PGA : participant assessed overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis). DAS28-4 (CRP) lower than (\<) 3.2 implied mild disease activity, 3.2 to 5.1 implied moderate disease activity and greater than (\>) 5.1 severe disease activity. Total score range: 0 to 9.4, higher score indicated more disease activity.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-0.743 units on a scale Standard Error 0.137	-0.892 units on a scale Standard Error 0.129	-1.101 units on a scale Standard Error 0.167	-0.881 units on a scale Standard Error 0.173	-0.433 units on a scale Standard Error 0.130
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-0.505 units on a scale Standard Error 0.139	-0.837 units on a scale Standard Error 0.131	-0.928 units on a scale Standard Error 0.169	-0.791 units on a scale Standard Error 0.178	-0.237 units on a scale Standard Error 0.132
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-0.787 units on a scale Standard Error 0.137	-0.920 units on a scale Standard Error 0.129	-1.062 units on a scale Standard Error 0.167	-0.782 units on a scale Standard Error 0.173	-0.516 units on a scale Standard Error 0.130
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-0.730 units on a scale Standard Error 0.137	-1.097 units on a scale Standard Error 0.129	-1.077 units on a scale Standard Error 0.167	-0.847 units on a scale Standard Error 0.173	-0.632 units on a scale Standard Error 0.130
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-1.012 units on a scale Standard Error 0.137	-1.108 units on a scale Standard Error 0.129	-1.174 units on a scale Standard Error 0.167	-0.804 units on a scale Standard Error 0.173	-0.659 units on a scale Standard Error 0.130
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-0.824 units on a scale Standard Error 0.145	-1.013 units on a scale Standard Error 0.131	-0.998 units on a scale Standard Error 0.176	-0.941 units on a scale Standard Error 0.181	-1.095 units on a scale Standard Error 0.136

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants Who Withdrew From Study Due to Lack of Efficacy	9 Participants	3 Participants	3 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12 and 16

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing/grooming, arising, eating, walking, reaching, gripping, hygiene, and "other common activities" over past week. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total average possible score range 0 (least difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 1	-0.166 units on a scale Standard Error 0.066	-0.323 units on a scale Standard Error 0.064	-0.291 units on a scale Standard Error 0.083	-0.144 units on a scale Standard Error 0.086	-0.046 units on a scale Standard Error 0.064
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 2	-0.286 units on a scale Standard Error 0.065	-0.341 units on a scale Standard Error 0.063	-0.370 units on a scale Standard Error 0.082	-0.201 units on a scale Standard Error 0.086	-0.151 units on a scale Standard Error 0.063
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 4	-0.241 units on a scale Standard Error 0.065	-0.343 units on a scale Standard Error 0.063	-0.405 units on a scale Standard Error 0.082	-0.258 units on a scale Standard Error 0.086	-0.186 units on a scale Standard Error 0.063
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 8	-0.159 units on a scale Standard Error 0.065	-0.409 units on a scale Standard Error 0.063	-0.391 units on a scale Standard Error 0.082	-0.192 units on a scale Standard Error 0.086	-0.219 units on a scale Standard Error 0.063
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 12	-0.253 units on a scale Standard Error 0.065	-0.433 units on a scale Standard Error 0.063	-0.356 units on a scale Standard Error 0.082	-0.142 units on a scale Standard Error 0.086	-0.220 units on a scale Standard Error 0.063
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16 Week 16	-0.263 units on a scale Standard Error 0.068	-0.280 units on a scale Standard Error 0.064	-0.245 units on a scale Standard Error 0.086	-0.210 units on a scale Standard Error 0.089	-0.346 units on a scale Standard Error 0.065

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8 and 12

The modified brief pain inventory-short form (mBPI-SF) is a pain assessment tool used to measure both pain intensity and pain interference using an 11-point numeric rating scale. Participants rated their pain severity, using a scale from 0 (no pain) to 10 (pain as bad as you can imagine), where higher scores indicate greater intensity of pain. Participants also rated the level of pain interference using a scale from 0 (no interference) to 10 (complete interference), where higher scores indicate more degree of interference in general daily activities.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Intensity: Week 1	-0.671 units on a scale Standard Error 0.247	-1.140 units on a scale Standard Error 0.236	-1.190 units on a scale Standard Error 0.309	-0.926 units on a scale Standard Error 0.325	-0.083 units on a scale Standard Error 0.239
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Intensity: Week 2	-0.929 units on a scale Standard Error 0.244	-1.069 units on a scale Standard Error 0.233	-1.507 units on a scale Standard Error 0.307	-1.004 units on a scale Standard Error 0.323	-0.487 units on a scale Standard Error 0.237
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Intensity: Week 4	-0.788 units on a scale Standard Error 0.244	-1.360 units on a scale Standard Error 0.233	-1.489 units on a scale Standard Error 0.307	-1.069 units on a scale Standard Error 0.323	-0.640 units on a scale Standard Error 0.237
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Intensity: Week 8	-0.640 units on a scale Standard Error 0.244	-1.383 units on a scale Standard Error 0.233	-1.379 units on a scale Standard Error 0.307	-0.870 units on a scale Standard Error 0.323	-0.616 units on a scale Standard Error 0.237
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Intensity: Week 12	-0.937 units on a scale Standard Error 0.244	-1.556 units on a scale Standard Error 0.233	-0.983 units on a scale Standard Error 0.307	-1.024 units on a scale Standard Error 0.323	-0.460 units on a scale Standard Error 0.237
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Interference:Week 1	-0.889 units on a scale Standard Error 0.265	-1.266 units on a scale Standard Error 0.253	-1.290 units on a scale Standard Error 0.331	-1.057 units on a scale Standard Error 0.349	-0.376 units on a scale Standard Error 0.257
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Interference:Week 2	-1.275 units on a scale Standard Error 0.262	-1.306 units on a scale Standard Error 0.251	-1.752 units on a scale Standard Error 0.329	-1.227 units on a scale Standard Error 0.347	-0.735 units on a scale Standard Error 0.255
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Interference:Week 4	-1.181 units on a scale Standard Error 0.262	-1.426 units on a scale Standard Error 0.251	-1.782 units on a scale Standard Error 0.329	-1.150 units on a scale Standard Error 0.347	-0.961 units on a scale Standard Error 0.255
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Interference:Week 8	-0.736 units on a scale Standard Error 0.262	-1.574 units on a scale Standard Error 0.251	-1.702 units on a scale Standard Error 0.329	-1.187 units on a scale Standard Error 0.347	-0.754 units on a scale Standard Error 0.255
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12 Pain Interference:Week 12	-1.030 units on a scale Standard Error 0.262	-1.615 units on a scale Standard Error 0.251	-1.433 units on a scale Standard Error 0.329	-1.187 units on a scale Standard Error 0.347	-0.820 units on a scale Standard Error 0.255

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12

The SF-36 version 2 is a 36-item generic health status measure standardized survey is a standardized survey evaluating 8 domains of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The summary score of these concepts is summarized as Physical component summary (PCS) score and Mental component summary (MCS) score, are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. The score for each of 8 domains were scaled from 0 (lowest level of functioning) to100 (highest level of functioning, where higher scores represented better level of functioning. 8 domains were summarized as 2 summary scores; PCS and MCS. Score range for each of the 2 summary scores = 0 (lowest level of functioning) to 100 (highest level of functioning), where higher scores represented better level of functioning.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 Week 4: PCS	2.374 units on a scale Standard Error 0.806	3.509 units on a scale Standard Error 0.777	5.778 units on a scale Standard Error 1.051	2.818 units on a scale Standard Error 1.074	1.582 units on a scale Standard Error 0.785
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 Week 12: PCS	2.857 units on a scale Standard Error 0.806	4.277 units on a scale Standard Error 0.773	4.525 units on a scale Standard Error 1.051	2.031 units on a scale Standard Error 1.056	1.763 units on a scale Standard Error 0.781
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 Week 4: MCS	1.676 units on a scale Standard Error 1.198	3.870 units on a scale Standard Error 1.144	4.897 units on a scale Standard Error 1.570	3.408 units on a scale Standard Error 1.602	2.579 units on a scale Standard Error 1.167
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12 Week 12: MCS	0.556 units on a scale Standard Error 1.198	2.656 units on a scale Standard Error 1.137	2.761 units on a scale Standard Error 1.570	2.341 units on a scale Standard Error 1.572	0.131 units on a scale Standard Error 1.161

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events are events between first dose of study drug and up to week 16 after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	38 Participants	47 Participants	31 Participants	33 Participants	42 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	3 Participants	4 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

Haemoglobin, haematocrit, red blood cell count less than(\<) 0.8\*lower limit of normal \[LLN\], platelets \<0.5\*LLN and (\&) greater than(\>) 1.75\*ULN, white blood cell count \<0.6\*LLN\&\>1.5x ULN, lymphocytes \<0.8\*LLN\&\>1.2\*ULN, total neutrophils \<0.8\*LLN\&\>1.2\*ULN, basophils, eosinophils, monocytes \>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase \>3.0\*ULN, total protein \<0.8\*LLN\&\>1.2\*ULN, albumin \<0.8\*LLN\&\>1.2\*ULN; blood urea nitrogen, Creatinine, Uric Acid \>1.2\*ULN; Cholesterol \>1.3\*ULN, HDL Cholesterol \<0.8\*LLN, LDL Cholesterol \>1.2\*ULN, Triglycerides \>1.3\*ULN; Electrolytes: sodium \<0.95\*LLN\&\>1.05\*ULN, potassium \<0.9\*LLN\&\>1.1\*ULN, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN\&\>1.1\*ULN, phosphate \<0.8\*LLN\&\>1.2x ULN; glucose \<0.6\*LLN\&\>1.5\*ULN, human chorionic gonadotrophin \>0; CRP \>1.25\*ULN, (\[urine-RBC, WBC, epithelial cells, crystals, yeast cells\] \>=6), urine casts \>1, urine Bacteria \>20.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Laboratory Abnormalities	68 Participants	72 Participants	43 Participants	40 Participants	74 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

Pre-defined criteria for vital sign abnormalities: Maximum (max) increase from baseline in supine systolic blood pressure (SBP) \>=30 milliliters of mercury (mmHg), maximum increase from baseline in supine diastolic blood pressure (DBP) \>=20 mmHg.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Clinically Significant Vital Signs Abnormalities Max Increase from Baseline in Supine SBP	4 Participants	6 Participants	4 Participants	7 Participants	8 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities Max Increase from Baseline in Supine DBP	4 Participants	9 Participants	2 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: FAS included all participants randomized to treatment and who had taken at least 1 dose of study medication.

12-lead ECG were performed after the participant had rested quietly for at least 10 minutes in a supine position. ECG parameters included RR interval, PR interval, QRS complex, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, Heart Rate and Fridericia's correction (QTcF) interval. Clinical significance of 12-Lead ECG was judged by investigator.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

Criteria for ECG abnormalities: maximum QT interval (millisecond \[msec\]): \< 450, 450 to \<480, 480 to \<500, \>= 500; maximum QT interval with Bazett's correction (QTcB interval) (msec): \<450, 450 to \<480, 480 to \<500, \>=500; maximum QT interval with Fridericia's correction (QTcF interval) (msec): \<450, 450 to \<480, 480 to \<500, \>=500; maximum QTc interval increase from baseline (msec): change \<30, 30 \<=change \<60, change \>=60.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QT Interval (450 to <480 msec)	4 Participants	11 Participants	5 Participants	6 Participants	7 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QT Interval (>=500 msec)	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcB Interval (450 to <480 msec)	14 Participants	24 Participants	12 Participants	15 Participants	13 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcB Interval (480 to <500 msec)	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcF Interval (<450 msec)	66 Participants	58 Participants	40 Participants	30 Participants	73 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTc Interval increase from baseline(change >=60 msec)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTc Interval increase from baseline(change 30 msec to <60 msec)	11 Participants	11 Participants	8 Participants	6 Participants	5 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QT Interval (<450 msec)	65 Participants	58 Participants	39 Participants	32 Participants	68 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QT Interval (480 to <500 msec)	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcB Interval (<450 msec)	54 Participants	46 Participants	32 Participants	25 Participants	61 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcB Interval (>=500 msec)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcF Interval (450 to <480 msec)	3 Participants	14 Participants	4 Participants	10 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcF Interval (480 to <500 msec)	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Maximum QTcF Interval (>=500 msec)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities QTc Interval increase from baseline(change < 30 msec)	57 Participants	62 Participants	36 Participants	34 Participants	70 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

Following criteria and body systems were examined to identify the clinically significant physical examination abnormalities; general appearance, skin (presence of rash), head, ears, eyes, nose, and throat, lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory function, coordination). Physical examination abnormalities were as determined by the investigator.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Clinically Significant Physical Examination Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose

Population: Analysis set included all participants randomized to treatment who had taken at least 1 dose of PH-797804.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State	5.4 Nanogram per milliliter Standard Deviation 1.8	30.8 Nanogram per milliliter Standard Deviation 8.9	51.3 Nanogram per milliliter Standard Deviation 15.9	79.4 Nanogram per milliliter Standard Deviation 26.4	—

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all participants randomized to treatment who had taken at least 1 dose of study drug.

Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.

Outcome measures

Outcome measures
Measure	PH-797804, 0.5 mg n=69 Participants Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 3 mg n=74 Participants Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 Participants Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 Participants Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 Participants Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Number of Participants With Concomitant Medications	69 Participants	73 Participants	44 Participants	40 Participants	74 Participants

Adverse Events

PH-797804, 0.5 mg

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

PH79804, 3 mg

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

PH-797804, 6 mg

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

PH-797804, 10 mg

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PH-797804, 0.5 mg n=69 participants at risk Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH79804, 3 mg n=74 participants at risk Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 participants at risk Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 participants at risk Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 participants at risk Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Cardiac disorders Myocardial infarction	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Colitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Gastritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Urinary tract infection	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Gastroenteritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Limb injury	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Pyrexia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Cyclitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Atrial fibrillation	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pneumonia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Acute coronary syndrome	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Presyncope	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Electrocardiogram change	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Dehydration	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Herpes simplex	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Oedema peripheral	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Hypovolaemic shock	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Sensory disturbance	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Diarrhoea	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Blood and lymphatic system disorders Anaemia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Abdominal pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Vomiting	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Viral infection	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.

Other adverse events

Other adverse events
Measure	PH-797804, 0.5 mg n=69 participants at risk Participants received PH-797804, 0.5 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH79804, 3 mg n=74 participants at risk Participants received PH-797804, 3 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 6 mg n=44 participants at risk Participants received PH-797804, 6 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	PH-797804, 10 mg n=40 participants at risk Participants received PH-797804, 10 mg capsule, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.	Placebo n=75 participants at risk Participants received placebo matched to PH-797804, orally, once daily for 12 weeks. Participants were followed up to 28 days after last dose of study drug. Individual participant participated in the study for a duration of up to 16 weeks.
Cardiac disorders Atrial fibrillation	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Palpitations	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Ventricular extrasystoles	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Atrioventricular block first degree	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Sinus tachycardia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Supraventricular tachycardia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Cheilitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Dental Caries	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Diarrhoea	5.8% 4/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.4% 4/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	9.1% 4/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	17.5% 7/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.3% 4/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Nausea	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.1% 3/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.0% 3/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Constipation	4.3% 3/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	7.5% 3/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.0% 3/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Dyspepsia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.1% 3/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.0% 3/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Gastritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Vomiting	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.4% 4/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Flatulance	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Abdominal pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Mouth ulceration	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Enterocolitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Oedema peripheral	5.8% 4/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Mass	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Thirst	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Asthenia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Chills	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Pyrexia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Malaise	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Oedema	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
General disorders Fatigue	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Psychiatric disorders Depression	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Psychiatric disorders Neurosis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Psychiatric disorders Anxiety	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Psychiatric disorders Insomnia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	10.0% 4/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.0% 3/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Flank pain	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Muscle spasms	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	6.8% 3/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	7.5% 3/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	8.0% 6/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.0% 3/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Neck pain	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Reproductive system and breast disorders Ovarian cyst	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Reproductive system and breast disorders Endometrial hyperplasia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Reproductive system and breast disorders Breast pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Reproductive system and breast disorders Menorrhagia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Blood and lymphatic system disorders Anaemia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Blood and lymphatic system disorders Eosinophilia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Hepatobiliary disorders Cholelithiasis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Hepatobiliary disorders Biliary colic	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Hepatobiliary disorders Hepatitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Skin nodule	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Dermatitis acneiform	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Pruritus	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.1% 3/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	6.8% 5/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Chloasma	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Dyshidrosis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Palpable purpura	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Nasopharyngitis	5.8% 4/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	12.5% 5/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Gastroenteritis	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Urinary tract infection	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.4% 4/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Parotitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Bronchitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.1% 3/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	7.5% 3/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	6.7% 5/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Paronychia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pharyngitis	4.3% 3/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	9.5% 7/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pneumonia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Tonsillitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Tinea versicolour	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Folliculitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Upper respiratory tract infection	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.4% 4/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Influenza	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.1% 3/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Cystitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Vulvovaginitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pyelonephritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pyelonephritis chronic	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Cellulitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Tinea pedis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Herpes simplex	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Dengue fever	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Impetigo	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Herpes zoster	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Bronchopneumonia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Vaginal candidiasis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Pharyngotonsillitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Dizziness	2.9% 2/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	12.5% 5/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Somnolence	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Sciatica	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Headache	5.8% 4/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Cervical root pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Tremor	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Radiculitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Allergic pharyngitis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Hypertension	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	6.8% 3/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	10.0% 4/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Thrombophlebitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Accelerated hypertension	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Haematoma	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Vision blurred	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Episcleritis	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Dry eye	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Corneal erosion	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Contusion	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Wound	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Injury, poisoning and procedural complications Fall	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Vascular disorders Hot flush	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Electrocardiogram T wave inversion	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Electrocardiogram T wave abnormal	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Electrocardiogram QT prolonged	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Haemoglobin decreased	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Blood triglycerides increased	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Electrocardiogram Q wave abnormal	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Blood pressure increased	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	5.0% 2/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Anorexia	1.4% 1/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Ear and labyrinth disorders Vertigo	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Surgical and medical procedures Tooth extraction	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Renal and urinary disorders Leukocyturia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Renal and urinary disorders Haematuria	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Cardiac disorders Bradycardia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Ocular hyperaemia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Eye disorders Conjunctivitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.7% 2/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Hypersomnia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Blood and lymphatic system disorders Leukopenia	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Sinusitis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Infections and infestations Urethritis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Platelet count increased	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Investigations Transaminases increased	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	4.5% 2/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.3% 1/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.3% 1/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	2.5% 1/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/69 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	1.4% 1/74 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/44 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/40 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.	0.00% 0/75 • Baseline up to Week 16 Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER