Trial Outcomes & Findings for Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis (NCT NCT01393639)

Last Updated: 2024-09-04

Results Overview

ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

323 participants

Primary outcome timeframe

Week 8

Results posted on

2024-09-04

Participant Flow

This multi-center, randomized, double-blind, parallel-group, active and placebo-controlled study randomized 323 participants in at 73 centers. An additional 34 centers had no screening activities, but received study medication; and an additional 17 centers had at least 1 participant screened, but did not randomize any participants.

Participants enrolled who had documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, had received methotrexate for at least 3 months to treat their rheumatoid arthritis, and were free of any signs or symptoms of infection.

Participant milestones

Participant milestones
Measure	PF-04171327 1 mg Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo Participants received placebo QD until week 12.
Overall Study STARTED	45	47	45	48	45	46	47
Overall Study COMPLETED	42	40	44	43	44	44	39
Overall Study NOT COMPLETED	3	7	1	5	1	2	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04171327 1 mg Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo Participants received placebo QD until week 12.
Overall Study Protocol Violation	0	0	0	1	0	0	0
Overall Study Other	0	2	0	2	1	0	1
Overall Study Withdrawal by Subject	1	1	0	0	0	0	1
Overall Study Medication error without associated AE	0	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	1	0	0	0	0	1
Overall Study Lack of Efficacy	0	0	0	0	0	0	1
Overall Study Adverse Event	2	3	1	2	0	2	3

Baseline Characteristics

Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.	Total n=323 Participants Total of all reporting groups
Age, Continuous	50.4 Years STANDARD_DEVIATION 14.2 • n=5 Participants	55.1 Years STANDARD_DEVIATION 12.1 • n=7 Participants	54.7 Years STANDARD_DEVIATION 13.1 • n=5 Participants	54.0 Years STANDARD_DEVIATION 11.1 • n=4 Participants	52.9 Years STANDARD_DEVIATION 11.2 • n=21 Participants	57.3 Years STANDARD_DEVIATION 10.7 • n=8 Participants	55.2 Years STANDARD_DEVIATION 13.2 • n=8 Participants	54.3 Years STANDARD_DEVIATION 12.3 • n=24 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	38 Participants n=7 Participants	34 Participants n=5 Participants	37 Participants n=4 Participants	39 Participants n=21 Participants	41 Participants n=8 Participants	37 Participants n=8 Participants	259 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	10 Participants n=8 Participants	64 Participants n=24 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Full Analysis Set (FAS) included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8	47 Percentage of participants	61 Percentage of participants	69 Percentage of participants	73 Percentage of participants	51 Percentage of participants	71 Percentage of participants	37 Percentage of participants

PRIMARY outcome

Timeframe: Week 8

Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.

Change from baseline in P1NP at week 8 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=42 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=43 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=44 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)	-3.25 Percent change Standard Error 5.50	-11.60 Percent change Standard Error 5.55	-9.96 Percent change Standard Error 5.49	-16.63 Percent change Standard Error 5.55	-4.89 Percent change Standard Error 5.55	-20.14 Percent change Standard Error 5.50	14.19 Percent change Standard Error 5.56

PRIMARY outcome

Timeframe: Week 8

Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=43 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=42 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=43 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=43 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=43 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=42 Participants Participants received placebo QD until week 12.
Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)	6.08 Percent change Standard Error 5.83	-3.78 Percent change Standard Error 5.88	6.96 Percent change Standard Error 5.86	15.57 Percent change Standard Error 5.83	2.74 Percent change Standard Error 5.87	-9.14 Percent change Standard Error 5.83	3.81 Percent change Standard Error 5.88

SECONDARY outcome

Timeframe: Weeks 2, 4, and 12 (taper period)

Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.

ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	31.82 Percentage of Participants 7.02	32.61 Percentage of Participants 6.91	40.00 Percentage of Participants 7.30	42.55 Percentage of Participants 7.21	28.89 Percentage of Participants 6.75	36.96 Percentage of Participants 7.11	20.45 Percentage of Participants 6.08
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	31.11 Percentage of Participants 6.90	55.32 Percentage of Participants 7.25	66.67 Percentage of Participants 7.02	53.19 Percentage of Participants 7.27	48.89 Percentage of Participants 7.45	65.22 Percentage of Participants 7.02	40.00 Percentage of Participants 7.30
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 12	35.56 Percentage of Participants 7.13	48.94 Percentage of Participants 7.29	55.56 Percentage of Participants 7.40	38.30 Percentage of Participants 7.09	48.89 Percentage of Participants 7.45	56.52 Percentage of Participants 7.30	33.33 Percentage of Participants 7.02

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, and 12 (taper period)

ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	4.55 Percentage of Participants 3.14	8.70 Percentage of Participants 4.15	8.89 Percentage of Participants 4.24	25.53 Percentage of Participants 6.36	2.22 Percentage of Participants 2.19	19.57 Percentage of Participants 5.84	6.82 Percentage of Participants 3.79
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	8.89 Percentage of Participants 4.24	23.40 Percentage of Participants 6.17	35.56 Percentage of Participants 7.13	27.66 Percentage of Participants 6.52	11.11 Percentage of Participants 4.68	30.43 Percentage of Participants 6.78	11.11 Percentage of Participants 4.68
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	11.11 Percentage of Participants 4.68	27.66 Percentage of Participants 6.52	40.00 Percentage of Participants 7.30	42.55 Percentage of Participants 7.21	24.44 Percentage of Participants 6.40	36.96 Percentage of Participants 7.11	15.56 Percentage of Participants 5.40
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	22.22 Percentage of Participants 6.19	31.91 Percentage of Participants 6.79	48.89 Percentage of Participants 7.45	42.55 Percentage of Participants 7.21	26.67 Percentage of Participants 6.59	45.65 Percentage of Participants 7.34	13.33 Percentage of Participants 5.16
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 12	17.78 Percentage of Participants 5.69	21.28 Percentage of Participants 5.96	24.44 Percentage of Participants 6.40	17.02 Percentage of Participants 5.48	26.67 Percentage of Participants 6.59	23.91 Percentage of Participants 6.28	17.78 Percentage of Participants 5.69

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, and 12 (taper period)

Population: Full analysis set was used. Note, N = number of participants in FAS and n = number of participants with observations in the below table.

ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	0.0 Percentage of Participants	4.35 Percentage of Participants	2.22 Percentage of Participants	6.38 Percentage of Participants	2.22 Percentage of Participants	8.70 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	0.0 Percentage of Participants	8.51 Percentage of Participants	15.56 Percentage of Participants	17.02 Percentage of Participants	4.44 Percentage of Participants	15.22 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	2.22 Percentage of Participants	12.77 Percentage of Participants	13.33 Percentage of Participants	17.02 Percentage of Participants	6.67 Percentage of Participants	21.74 Percentage of Participants	4.44 Percentage of Participants
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	8.89 Percentage of Participants	17.02 Percentage of Participants	26.67 Percentage of Participants	21.28 Percentage of Participants	6.67 Percentage of Participants	26.09 Percentage of Participants	11.11 Percentage of Participants
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) Week 12	6.67 Percentage of Participants	12.77 Percentage of Participants	6.67 Percentage of Participants	8.51 Percentage of Participants	11.11 Percentage of Participants	10.87 Percentage of Participants	6.67 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-4.08 Joints Standard Error 0.74	-5.55 Joints Standard Error 0.72	-4.97 Joints Standard Error 0.73	-5.65 Joints Standard Error 0.72	-3.88 Joints Standard Error 0.73	-5.38 Joints Standard Error 0.72	-1.95 Joints Standard Error 0.74
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-5.97 Joints Standard Error 0.80	-6.99 Joints Standard Error 0.79	-7.01 Joints Standard Error 0.80	-6.93 Joints Standard Error 0.79	-5.79 Joints Standard Error 0.80	-7.44 Joints Standard Error 0.79	-4.16 Joints Standard Error 0.80
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-6.87 Joints Standard Error 0.87	-8.83 Joints Standard Error 0.87	-8.37 Joints Standard Error 0.87	-8.31 Joints Standard Error 0.86	-6.91 Joints Standard Error 0.87	-8.75 Joints Standard Error 0.86	-4.64 Joints Standard Error 0.87
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-7.06 Joints Standard Error 0.91	-8.65 Joints Standard Error 0.92	-9.46 Joints Standard Error 0.91	-9.17 Joints Standard Error 0.91	-7.00 Joints Standard Error 0.91	-8.84 Joints Standard Error 0.90	-4.27 Joints Standard Error 0.92

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=43 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)	-6.25 Joints Standard Deviation 6.77	-7.24 Joints Standard Deviation 6.13	-6.16 Joints Standard Deviation 6.40	-6.47 Joints Standard Deviation 7.54	-7.07 Joints Standard Deviation 5.89	-8.16 Joints Standard Deviation 4.66	-5.59 Joints Standard Deviation 6.67

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-3.42 Joints Standard Error 0.62	-4.70 Joints Standard Error 0.61	-4.27 Joints Standard Error 0.62	-5.36 Joints Standard Error 0.61	-3.65 Joints Standard Error 0.62	-5.04 Joints Standard Error 0.61	-2.25 Joints Standard Error 0.62
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-5.54 Joints Standard Error 0.70	-5.85 Joints Standard Error 0.71	-5.94 Joints Standard Error 0.70	-7.00 Joints Standard Error 0.70	-5.75 Joints Standard Error 0.71	-6.71 Joints Standard Error 0.70	-3.87 Joints Standard Error 0.70
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-6.26 Joints Standard Error 0.69	-6.90 Joints Standard Error 0.70	-7.36 Joints Standard Error 0.69	-7.68 Joints Standard Error 0.69	-6.89 Joints Standard Error 0.69	-8.02 Joints Standard Error 0.69	-4.94 Joints Standard Error 0.69
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-6.50 Joints Standard Error 0.79	-7.45 Joints Standard Error 0.80	-7.95 Joints Standard Error 0.79	-7.83 Joints Standard Error 0.79	-6.90 Joints Standard Error 0.79	-8.38 Joints Standard Error 0.78	-4.51 Joints Standard Error 0.80

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=43 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)	-6.20 Joints Standard Deviation 6.21	-5.98 Joints Standard Deviation 4.81	-5.86 Joints Standard Deviation 6.17	-5.58 Joints Standard Deviation 6.24	-7.43 Joints Standard Deviation 5.82	-7.07 Joints Standard Deviation 5.02	-6.17 Joints Standard Deviation 5.48

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) Week 2	-7.29 mg/L Standard Error 2.89	-12.95 mg/L Standard Error 2.82	-13.73 mg/L Standard Error 2.87	-18.92 mg/L Standard Error 2.78	-8.25 mg/L Standard Error 2.87	-16.90 mg/L Standard Error 2.86	-2.80 mg/L Standard Error 2.89
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) Week 4	-9.77 mg/L Standard Error 2.77	-14.33 mg/L Standard Error 2.78	-11.52 mg/L Standard Error 2.81	-16.57 mg/L Standard Error 2.75	-3.92 mg/L Standard Error 2.81	-17.49 mg/L Standard Error 2.76	-6.35 mg/L Standard Error 2.77
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) Week 6	-9.35 mg/L Standard Error 2.51	-16.16 mg/L Standard Error 2.53	-13.05 mg/L Standard Error 2.49	-13.81 mg/L Standard Error 2.51	-6.54 mg/L Standard Error 2.52	-16.85 mg/L Standard Error 2.46	-3.93 mg/L Standard Error 2.53
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) Week 8	-7.29 mg/L Standard Error 2.49	-14.28 mg/L Standard Error 2.52	-14.86 mg/L Standard Error 2.47	-11.98 mg/L Standard Error 2.49	-7.23 mg/L Standard Error 2.50	-17.59 mg/L Standard Error 2.44	-4.19 mg/L Standard Error 2.49

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=42 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=39 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=43 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=42 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=43 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=39 Participants Participants received placebo QD until week 12.
Change From Baseline of CRP at Week 12 (Descriptive Statistics)	0.72 mg/L Standard Deviation 27.40	-6.24 mg/L Standard Deviation 23.06	-4.52 mg/L Standard Deviation 20.35	-0.64 mg/L Standard Deviation 29.08	-2.90 mg/L Standard Deviation 16.10	-9.39 mg/L Standard Deviation 36.10	-4.07 mg/L Standard Deviation 22.10

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-10.24 mm Standard Error 2.85	-18.77 mm Standard Error 2.79	-24.72 mm Standard Error 2.83	-22.50 mm Standard Error 2.77	-10.04 mm Standard Error 2.83	-23.51 mm Standard Error 2.84	-10.61 mm Standard Error 2.85
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-14.93 mm Standard Error 3.21	-24.04 mm Standard Error 3.22	-27.98 mm Standard Error 3.24	-23.14 mm Standard Error 3.19	-17.16 mm Standard Error 3.24	-28.31 mm Standard Error 3.24	-14.56 mm Standard Error 3.21
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-18.77 mm Standard Error 3.28	-30.84 mm Standard Error 3.28	-35.00 mm Standard Error 3.27	-27.93 mm Standard Error 3.24	-23.07 mm Standard Error 3.27	-32.34 mm Standard Error 3.27	-18.55 mm Standard Error 3.26
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-16.51 mm Standard Error 3.49	-29.08 mm Standard Error 3.52	-36.88 mm Standard Error 3.50	-31.32 mm Standard Error 3.47	-25.82 mm Standard Error 3.50	-34.60 mm Standard Error 3.51	-18.36 mm Standard Error 3.51

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)	-14.54 mm Standard Deviation 27.33	-22.26 mm Standard Deviation 26.11	-18.10 mm Standard Deviation 25.35	-16.74 mm Standard Deviation 31.57	-19.24 mm Standard Deviation 29.32	-25.29 mm Standard Deviation 29.20	-17.90 mm Standard Deviation 23.14

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-16.35 mm Standard Error 2.53	-21.74 mm Standard Error 2.45	-22.14 mm Standard Error 2.48	-25.21 mm Standard Error 2.43	-13.24 mm Standard Error 2.48	-22.80 mm Standard Error 2.48	-9.29 mm Standard Error 2.50
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-22.25 mm Standard Error 2.68	-27.03 mm Standard Error 2.64	-30.72 mm Standard Error 2.66	-28.95 mm Standard Error 2.62	-20.94 mm Standard Error 2.66	-31.16 mm Standard Error 2.66	-15.00 mm Standard Error 2.64
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-25.58 mm Standard Error 2.68	-32.54 mm Standard Error 2.67	-34.79 mm Standard Error 2.66	-32.79 mm Standard Error 2.63	-28.54 mm Standard Error 2.66	-33.92 mm Standard Error 2.66	-19.48 mm Standard Error 2.65
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-26.24 mm Standard Error 2.81	-33.92 mm Standard Error 2.82	-38.00 mm Standard Error 2.79	-33.71 mm Standard Error 2.77	-29.25 mm Standard Error 2.79	-35.50 mm Standard Error 2.79	-21.52 mm Standard Error 2.79

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=43 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=40 Participants Participants received placebo QD until week 12.
Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)	-25.00 mm Standard Deviation 21.57	-28.56 mm Standard Deviation 26.41	-23.04 mm Standard Deviation 22.00	-24.30 mm Standard Deviation 28.15	-27.25 mm Standard Deviation 23.71	-27.25 mm Standard Deviation 20.42	-19.34 mm Standard Deviation 27.21

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-13.41 mm Standard Error 2.88	-17.40 mm Standard Error 2.83	-24.90 mm Standard Error 2.86	-22.86 mm Standard Error 2.80	-12.68 mm Standard Error 2.86	-24.59 mm Standard Error 2.87	-10.54 mm Standard Error 2.88
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-15.55 mm Standard Error 3.08	-24.38 mm Standard Error 3.09	-29.70 mm Standard Error 3.10	-26.08 mm Standard Error 3.05	-20.26 mm Standard Error 3.10	-29.65 mm Standard Error 3.11	-14.28 mm Standard Error 3.08
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-19.03 mm Standard Error 3.33	-29.16 mm Standard Error 3.35	-34.37 mm Standard Error 3.33	-30.15 mm Standard Error 3.30	-24.16 mm Standard Error 3.33	-34.69 mm Standard Error 3.34	-18.80 mm Standard Error 3.32
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-18.95 mm Standard Error 3.45	-28.53 mm Standard Error 3.50	-37.96 mm Standard Error 3.46	-30.91 mm Standard Error 3.43	-25.86 mm Standard Error 3.46	-37.60 mm Standard Error 3.47	-18.26 mm Standard Error 3.47

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=40 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)	-17.86 mm Standard Deviation 26.70	-19.40 mm Standard Deviation 29.04	-18.23 mm Standard Deviation 27.75	-16.60 mm Standard Deviation 30.50	-21.52 mm Standard Deviation 24.69	-25.17 mm Standard Deviation 29.60	-16.30 mm Standard Deviation 22.41

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and 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 possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-0.25 Units on a scale Standard Error 0.06	-0.34 Units on a scale Standard Error 0.06	-0.33 Units on a scale Standard Error 0.06	-0.41 Units on a scale Standard Error 0.06	-0.23 Units on a scale Standard Error 0.06	-0.41 Units on a scale Standard Error 0.06	-0.05 Units on a scale Standard Error 0.06
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-0.26 Units on a scale Standard Error 0.07	-0.50 Units on a scale Standard Error 0.07	-0.43 Units on a scale Standard Error 0.07	-0.51 Units on a scale Standard Error 0.07	-0.34 Units on a scale Standard Error 0.07	-0.58 Units on a scale Standard Error 0.07	-0.14 Units on a scale Standard Error 0.07
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-0.35 Units on a scale Standard Error 0.07	-0.60 Units on a scale Standard Error 0.07	-0.52 Units on a scale Standard Error 0.07	-0.56 Units on a scale Standard Error 0.07	-0.39 Units on a scale Standard Error 0.07	-0.68 Units on a scale Standard Error 0.07	-0.21 Units on a scale Standard Error 0.07
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-0.26 Units on a scale Standard Error 0.08	-0.59 Units on a scale Standard Error 0.08	-0.60 Units on a scale Standard Error 0.08	-0.55 Units on a scale Standard Error 0.08	-0.50 Units on a scale Standard Error 0.08	-0.77 Units on a scale Standard Error 0.08	-0.19 Units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)	-0.28 Units on a scale Standard Deviation 0.63	-0.57 Units on a scale Standard Deviation 0.65	-0.37 Units on a scale Standard Deviation 0.50	-0.38 Units on a scale Standard Deviation 0.50	-0.52 Units on a scale Standard Deviation 0.63	-0.56 Units on a scale Standard Deviation 0.59	-0.26 Units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-0.81 Units on a scale Standard Error 0.13	-1.15 Units on a scale Standard Error 0.13	-1.21 Units on a scale Standard Error 0.13	-1.51 Units on a scale Standard Error 0.13	-0.75 Units on a scale Standard Error 0.13	-1.23 Units on a scale Standard Error 0.13	-0.40 Units on a scale Standard Error 0.13
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-1.19 Units on a scale Standard Error 0.15	-1.49 Units on a scale Standard Error 0.15	-1.71 Units on a scale Standard Error 0.15	-1.73 Units on a scale Standard Error 0.15	-1.01 Units on a scale Standard Error 0.15	-1.67 Units on a scale Standard Error 0.15	-0.76 Units on a scale Standard Error 0.15
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-1.38 Units on a scale Standard Error 0.16	-1.81 Units on a scale Standard Error 0.16	-2.01 Units on a scale Standard Error 0.16	-1.99 Units on a scale Standard Error 0.16	-1.37 Units on a scale Standard Error 0.16	-1.98 Units on a scale Standard Error 0.16	-0.94 Units on a scale Standard Error 0.16
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-1.44 Units on a scale Standard Error 0.17	-1.84 Units on a scale Standard Error 0.17	-2.22 Units on a scale Standard Error 0.17	-2.13 Units on a scale Standard Error 0.17	-1.42 Units on a scale Standard Error 0.17	-2.14 Units on a scale Standard Error 0.17	-0.93 Units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=43 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=41 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=43 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=40 Participants Participants received placebo QD until week 12.
Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)	-1.30 Units on a scale Standard Deviation 1.21	-1.37 Units on a scale Standard Deviation 1.05	-1.29 Units on a scale Standard Deviation 1.14	-1.25 Units on a scale Standard Deviation 1.36	-1.45 Units on a scale Standard Deviation 1.05	-1.62 Units on a scale Standard Deviation 1.00	-1.13 Units on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, and 8

DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 2	-0.88 Units on a scale Standard Error 0.14	-1.29 Units on a scale Standard Error 0.14	-1.45 Units on a scale Standard Error 0.14	-1.69 Units on a scale Standard Error 0.14	-0.82 Units on a scale Standard Error 0.14	-1.46 Units on a scale Standard Error 0.14	-0.52 Units on a scale Standard Error 0.14
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	-1.29 Units on a scale Standard Error 0.16	-1.68 Units on a scale Standard Error 0.16	-1.97 Units on a scale Standard Error 0.16	-1.90 Units on a scale Standard Error 0.16	-1.15 Units on a scale Standard Error 0.16	-1.92 Units on a scale Standard Error 0.16	-0.90 Units on a scale Standard Error 0.16
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 6	-1.51 Units on a scale Standard Error 0.18	-2.06 Units on a scale Standard Error 0.18	-2.32 Units on a scale Standard Error 0.18	-2.21 Units on a scale Standard Error 0.18	-1.56 Units on a scale Standard Error 0.18	-2.27 Units on a scale Standard Error 0.18	-1.12 Units on a scale Standard Error 0.18
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	-1.55 Units on a scale Standard Error 0.19	-2.07 Units on a scale Standard Error 0.19	-2.53 Units on a scale Standard Error 0.19	-2.38 Units on a scale Standard Error 0.19	-1.65 Units on a scale Standard Error 0.19	-2.44 Units on a scale Standard Error 0.19	-1.11 Units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=43 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=41 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=44 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=40 Participants Participants received placebo QD until week 12.
Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)	-1.39 Units on a scale Standard Deviation 1.31	-1.56 Units on a scale Standard Deviation 1.17	-1.42 Units on a scale Standard Deviation 1.19	-1.38 Units on a scale Standard Deviation 1.47	-1.59 Units on a scale Standard Deviation 1.22	-1.80 Units on a scale Standard Deviation 1.14	-1.29 Units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Weeks 4 and 8

The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	3.59 Units on a scale Standard Error 1.28	4.53 Units on a scale Standard Error 1.26	5.22 Units on a scale Standard Error 1.30	5.74 Units on a scale Standard Error 1.25	3.67 Units on a scale Standard Error 1.29	7.23 Units on a scale Standard Error 1.29	4.98 Units on a scale Standard Error 1.28
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	2.57 Units on a scale Standard Error 1.39	6.07 Units on a scale Standard Error 1.41	6.03 Units on a scale Standard Error 1.40	6.47 Units on a scale Standard Error 1.39	5.30 Units on a scale Standard Error 1.40	8.76 Units on a scale Standard Error 1.40	4.58 Units on a scale Standard Error 1.39

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=43 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)	3.35 Units on a scale Standard Deviation 11.99	4.19 Units on a scale Standard Deviation 9.19	0.48 Units on a scale Standard Deviation 8.97	2.72 Units on a scale Standard Deviation 10.67	3.08 Units on a scale Standard Deviation 12.91	6.11 Units on a scale Standard Deviation 12.90	4.69 Units on a scale Standard Deviation 10.72

SECONDARY outcome

Timeframe: Weeks 4 and 8

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=45 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 Participants Participants received placebo QD until week 12.
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 4	3.84 Units on a scale Standard Error 0.92	5.00 Units on a scale Standard Error 0.91	8.22 Units on a scale Standard Error 0.93	6.83 Units on a scale Standard Error 0.90	4.28 Units on a scale Standard Error 0.93	7.51 Units on a scale Standard Error 0.93	2.10 Units on a scale Standard Error 0.92
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) Week 8	5.24 Units on a scale Standard Error 1.03	7.85 Units on a scale Standard Error 1.04	9.65 Units on a scale Standard Error 1.03	7.15 Units on a scale Standard Error 1.02	7.06 Units on a scale Standard Error 1.03	9.62 Units on a scale Standard Error 1.03	3.45 Units on a scale Standard Error 1.03

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	PF-04171327 1 mg n=44 Participants Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=41 Participants Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=44 Participants Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=43 Participants Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=43 Participants Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=42 Participants Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=41 Participants Participants received placebo QD until week 12.
Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)	4.64 Units on a scale Standard Deviation 8.21	5.39 Units on a scale Standard Deviation 7.05	7.42 Units on a scale Standard Deviation 8.56	3.91 Units on a scale Standard Deviation 7.16	7.63 Units on a scale Standard Deviation 7.95	5.85 Units on a scale Standard Deviation 7.32	3.23 Units on a scale Standard Deviation 4.80

Adverse Events

PF-04171327 1 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

PF-04171327 5 mg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

PF-04171327 10 mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

PF-04171327 15 mg

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Prednisone 5 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Prednisone 10 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-04171327 1 mg n=45 participants at risk Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 participants at risk Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 participants at risk Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 participants at risk Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 participants at risk Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 participants at risk Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 participants at risk Participants received placebo QD until week 12.
Infections and infestations Bronchitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Cholecystitis infective	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Coronary artery disease	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	PF-04171327 1 mg n=45 participants at risk Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 5 mg n=47 participants at risk Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 10 mg n=45 participants at risk Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	PF-04171327 15 mg n=48 participants at risk Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.	Prednisone 5 mg n=45 participants at risk Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Prednisone 10 mg n=46 participants at risk Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.	Placebo n=47 participants at risk Participants received placebo QD until week 12.
Blood and lymphatic system disorders Anaemia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Eosinophilia	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Monocytosis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Bradycardia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Extrasystoles	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus bradycardia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus tachycardia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders Adrenal insufficiency	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders Goitre	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Astigmatism	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Dry eye	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Presbyopia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Visual impairment	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.4% 2/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.4% 2/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 2/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Food poisoning	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.4% 2/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral discomfort	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chills	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 2/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Drug ineffective	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Face oedema	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Feeling hot	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Local swelling	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 2/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Abscess bacterial	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Candida infection	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gingivitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes virus infection	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.4% 3/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.7% 3/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis bacterial	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection viral	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.7% 3/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral rhinitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ligament sprain	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	4.4% 2/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.9% 4/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.5% 3/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.4% 3/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 2/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood bilirubin increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine decreased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Body temperature increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Weight increased	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Polydipsia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	10.9% 5/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.7% 3/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.3% 2/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.4% 2/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	4.2% 2/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.7% 3/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.7% 4/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Presyncope	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sciatica	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Microalbuminuria	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nocturia	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Polymenorrhoea	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Knee operation	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Tooth extraction	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Flushing	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	6.4% 3/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Varicose vein	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/45 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.2% 1/46 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/47 • 13 weeks All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

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