Trial Outcomes & Findings for Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis (NCT NCT00413660)

NCT ID: NCT00413660

Last Updated: 2013-01-18

Results Overview

ACR20 response: \>= 20% improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); 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: 509 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2013-01-18

Participant Flow

Participant milestones

Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily for 24 weeks.	CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 20 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Up To Week 12 STARTED	71	68	71	75	75	80	69	0	0	0	0
Up To Week 12 Treated	70	68	71	74	75	80	69	0	0	0	0
Up To Week 12 COMPLETED	64	61	64	67	66	70	58	0	0	0	0
Up To Week 12 NOT COMPLETED	7	7	7	8	9	10	11	0	0	0	0
Post Week 12 STARTED	43	48	64	67	66	57	40	21	13	13	18
Post Week 12 COMPLETED	40	44	56	66	60	54	37	21	13	12	17
Post Week 12 NOT COMPLETED	3	4	8	1	6	3	3	0	0	1	1

Reasons for withdrawal

Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily for 24 weeks.	CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 20 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Up To Week 12 Adverse Event	1	3	1	4	6	4	1	0	0	0	0
Up To Week 12 Lack of Efficacy	2	0	0	0	0	0	5	0	0	0	0
Up To Week 12 Lost to Follow-up	0	1	0	0	1	0	0	0	0	0	0
Up To Week 12 Withdrawal by Subject	0	2	0	2	0	2	2	0	0	0	0
Up To Week 12 Randomized, Not Treated	1	0	0	1	0	0	0	0	0	0	0
Up To Week 12 Other	3	1	6	1	2	4	3	0	0	0	0
Post Week 12 Adverse Event	2	0	2	1	4	2	2	0	0	0	0
Post Week 12 Lack of Efficacy	0	0	1	0	0	0	0	0	0	1	0
Post Week 12 Lost to Follow-up	0	1	1	0	0	0	0	0	0	0	0
Post Week 12 Withdrawal by Subject	0	1	1	0	1	0	0	0	0	0	1
Post Week 12 Other	1	2	3	0	1	1	1	0	0	0	0

Baseline Characteristics

Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Total n=507 Participants Total of all reporting groups
Age, Customized 18 to 44 Years	15 participants n=5 Participants	23 participants n=7 Participants	19 participants n=5 Participants	9 participants n=4 Participants	14 participants n=21 Participants	15 participants n=10 Participants	17 participants n=115 Participants	112 participants n=24 Participants
Age, Customized 45 to 64 Years	47 participants n=5 Participants	31 participants n=7 Participants	42 participants n=5 Participants	49 participants n=4 Participants	49 participants n=21 Participants	49 participants n=10 Participants	40 participants n=115 Participants	307 participants n=24 Participants
Age, Customized Greater Than or Equal to (>=) 65 Years	8 participants n=5 Participants	14 participants n=7 Participants	10 participants n=5 Participants	16 participants n=4 Participants	12 participants n=21 Participants	16 participants n=10 Participants	12 participants n=115 Participants	88 participants n=24 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	52 Participants n=7 Participants	57 Participants n=5 Participants	55 Participants n=4 Participants	66 Participants n=21 Participants	63 Participants n=10 Participants	56 Participants n=115 Participants	406 Participants n=24 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	19 Participants n=4 Participants	9 Participants n=21 Participants	17 Participants n=10 Participants	13 Participants n=115 Participants	101 Participants n=24 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).

ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); 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).

Outcome measures

Measure	CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=68 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=71 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=74 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=75 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=80 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=69 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	—	—	—	—	47.14 percentage of participants	55.88 percentage of participants	56.34 percentage of participants	58.11 percentage of participants	56.00 percentage of participants	56.25 percentage of participants	36.23 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.

ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; 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 HAQ); and CRP.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=18 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)	33.75 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.94 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.43 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.76 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.99 percentage of participants	31.08 percentage of participants	40.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)	51.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.64 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.14 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.59 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.48 percentage of participants	45.95 percentage of participants	54.67 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)	50.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.68 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.29 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.41 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	57.75 percentage of participants	55.41 percentage of participants	56.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)	56.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.41 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.93 percentage of participants	56.76 percentage of participants	64.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)	64.2 percentage of participants	0.0 percentage of participants	43.1 percentage of participants	0.0 percentage of participants	63.3 percentage of participants	0.0 percentage of participants	60.0 percentage of participants	0.0 percentage of participants	53.5 percentage of participants	64.9 percentage of participants	62.7 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)	64.2 percentage of participants	0.0 percentage of participants	47.1 percentage of participants	0.0 percentage of participants	59.2 percentage of participants	0.0 percentage of participants	67.3 percentage of participants	0.0 percentage of participants	57.7 percentage of participants	62.2 percentage of participants	61.3 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)	62.7 percentage of participants	0.0 percentage of participants	47.1 percentage of participants	0.0 percentage of participants	59.2 percentage of participants	0.0 percentage of participants	65.5 percentage of participants	0.0 percentage of participants	59.2 percentage of participants	66.2 percentage of participants	65.3 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.

ACR50 response: >= 50% improvement in TJC or SJC and 50% 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 HAQ); and CRP.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=18 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)	25.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.90 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.29 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.18 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.27 percentage of participants	20.27 percentage of participants	26.67 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)	47.8 percentage of participants	0.0 percentage of participants	31.4 percentage of participants	0.0 percentage of participants	38.8 percentage of participants	0.0 percentage of participants	45.5 percentage of participants	0.0 percentage of participants	38.0 percentage of participants	40.5 percentage of participants	48.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)	46.3 percentage of participants	0.0 percentage of participants	31.4 percentage of participants	0.0 percentage of participants	44.9 percentage of participants	0.0 percentage of participants	34.5 percentage of participants	0.0 percentage of participants	39.4 percentage of participants	39.2 percentage of participants	46.7 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)	15.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.90 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.43 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.88 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.63 percentage of participants	4.05 percentage of participants	17.33 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)	27.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.70 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.41 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.99 percentage of participants	27.03 percentage of participants	32.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)	32.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.39 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.14 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.35 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.39 percentage of participants	28.38 percentage of participants	41.33 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 12 (n=70,0,68,0,71,74,75,80,0,69,0)	36.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.39 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.86 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.41 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.62 percentage of participants	28.38 percentage of participants	44.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)	41.8 percentage of participants	0.0 percentage of participants	21.6 percentage of participants	0.0 percentage of participants	38.8 percentage of participants	0.0 percentage of participants	43.6 percentage of participants	0.0 percentage of participants	38.0 percentage of participants	36.5 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.

ACR70 response: >= 70% improvement in TJC or SJC and 70% 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 HAQ); and CRP.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=18 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)	2.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.43 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.47 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.41 percentage of participants	1.35 percentage of participants	6.67 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12 (n=70,0,68,0,71,74,75,80,0,69,0)	23.75 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.80 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.29 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.59 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.31 percentage of participants	12.16 percentage of participants	24.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)	12.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.45 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.86 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.35 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	14.86 percentage of participants	13.33 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)	12.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.35 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.43 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.24 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.90 percentage of participants	9.46 percentage of participants	16.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)	17.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.80 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.57 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.71 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.27 percentage of participants	16.22 percentage of participants	16.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)	22.4 percentage of participants	0.0 percentage of participants	9.8 percentage of participants	0.0 percentage of participants	16.3 percentage of participants	0.0 percentage of participants	21.8 percentage of participants	0.0 percentage of participants	18.3 percentage of participants	18.9 percentage of participants	24.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)	28.4 percentage of participants	0.0 percentage of participants	13.7 percentage of participants	0.0 percentage of participants	20.4 percentage of participants	0.0 percentage of participants	29.1 percentage of participants	0.0 percentage of participants	23.9 percentage of participants	24.3 percentage of participants	28.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)	28.4 percentage of participants	0.0 percentage of participants	9.8 percentage of participants	0.0 percentage of participants	28.6 percentage of participants	0.0 percentage of participants	23.6 percentage of participants	0.0 percentage of participants	21.1 percentage of participants	18.9 percentage of participants	32.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 2, 4, 6, 8, 12

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).

ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

Outcome measures

Measure	CP-690,550 20 mg CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=68 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=71 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=74 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=75 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=80 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=69 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 2	—	—	—	—	-14.07 units on a scale Standard Deviation 247.36	22.16 units on a scale Standard Deviation 243.19	4.47 units on a scale Standard Deviation 319.92	-21.34 units on a scale Standard Deviation 661.05	88.72 units on a scale Standard Deviation 287.91	36.55 units on a scale Standard Deviation 267.26	-113.31 units on a scale Standard Deviation 429.17
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 4	—	—	—	—	61.66 units on a scale Standard Deviation 622.43	163.40 units on a scale Standard Deviation 659.05	92.24 units on a scale Standard Deviation 919.49	7.29 units on a scale Standard Deviation 2038.26	341.52 units on a scale Standard Deviation 820.16	170.23 units on a scale Standard Deviation 825.49	-296.38 units on a scale Standard Deviation 1270.69
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 6	—	—	—	—	244.11 units on a scale Standard Deviation 948.25	442.29 units on a scale Standard Deviation 1087.57	348.96 units on a scale Standard Deviation 1446.07	111.83 units on a scale Standard Deviation 3626.48	716.69 units on a scale Standard Deviation 1285.36	402.21 units on a scale Standard Deviation 1428.69	-453.18 units on a scale Standard Deviation 2265.12
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 8	—	—	—	—	464.42 units on a scale Standard Deviation 1424.59	772.65 units on a scale Standard Deviation 1594.84	693.90 units on a scale Standard Deviation 1952.07	239.54 units on a scale Standard Deviation 5389.58	1154.14 units on a scale Standard Deviation 1733.13	725.67 units on a scale Standard Deviation 1954.96	-571.99 units on a scale Standard Deviation 3310.17
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 12	—	—	—	—	995.34 units on a scale Standard Deviation 2349.99	1511.40 units on a scale Standard Deviation 2711.76	1420.20 units on a scale Standard Deviation 3284.51	588.45 units on a scale Standard Deviation 8969.29	1974.18 units on a scale Standard Deviation 3231.70	1504.58 units on a scale Standard Deviation 2979.75	-755.22 units on a scale Standard Deviation 5107.45

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Tender Joints Count (TJC) Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	13.22 tender joints Standard Deviation 13.25	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.74 tender joints Standard Deviation 13.86	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.48 tender joints Standard Deviation 12.18	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.12 tender joints Standard Deviation 9.56	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.23 tender joints Standard Deviation 10.44	13.55 tender joints Standard Deviation 14.38	11.51 tender joints Standard Deviation 12.67
Tender Joints Count (TJC) Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	11.15 tender joints Standard Deviation 13.76	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.57 tender joints Standard Deviation 14.16	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.24 tender joints Standard Deviation 12.50	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.18 tender joints Standard Deviation 10.30	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.82 tender joints Standard Deviation 11.08	12.22 tender joints Standard Deviation 13.75	9.49 tender joints Standard Deviation 11.71
Tender Joints Count (TJC) Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	6.51 tender joints Standard Deviation 10.55	23.00 tender joints Standard Deviation 16.59	7.62 tender joints Standard Deviation 7.26	15.24 tender joints Standard Deviation 17.68	8.08 tender joints Standard Deviation 11.06	13.76 tender joints Standard Deviation 12.02	5.32 tender joints Standard Deviation 6.35	15.00 tender joints Standard Deviation 11.47	7.16 tender joints Standard Deviation 9.91	8.27 tender joints Standard Deviation 11.32	6.98 tender joints Standard Deviation 9.96
Tender Joints Count (TJC) Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)	5.87 tender joints Standard Deviation 7.68	21.67 tender joints Standard Deviation 13.69	5.33 tender joints Standard Deviation 5.74	15.88 tender joints Standard Deviation 17.46	7.45 tender joints Standard Deviation 10.88	14.80 tender joints Standard Deviation 14.09	5.52 tender joints Standard Deviation 5.65	13.92 tender joints Standard Deviation 9.93	6.85 tender joints Standard Deviation 9.51	8.20 tender joints Standard Deviation 9.94	6.37 tender joints Standard Deviation 8.72
Tender Joints Count (TJC) Baseline (n=70,0,68,0,71,74,75,80,0,69,0)	23.11 tender joints Standard Deviation 12.67	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.59 tender joints Standard Deviation 13.18	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.64 tender joints Standard Deviation 11.60	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.79 tender joints Standard Deviation 10.57	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.46 tender joints Standard Deviation 12.95	24.84 tender joints Standard Deviation 12.51	23.68 tender joints Standard Deviation 12.71
Tender Joints Count (TJC) Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	15.33 tender joints Standard Deviation 12.59	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.86 tender joints Standard Deviation 13.00	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.62 tender joints Standard Deviation 12.09	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.71 tender joints Standard Deviation 11.87	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.56 tender joints Standard Deviation 10.44	17.34 tender joints Standard Deviation 12.13	16.32 tender joints Standard Deviation 13.18
Tender Joints Count (TJC) Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	13.75 tender joints Standard Deviation 13.08	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.17 tender joints Standard Deviation 12.36	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.01 tender joints Standard Deviation 11.19	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.80 tender joints Standard Deviation 10.36	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.06 tender joints Standard Deviation 11.59	14.01 tender joints Standard Deviation 14.73	13.00 tender joints Standard Deviation 12.48
Tender Joints Count (TJC) Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)	11.27 tender joints Standard Deviation 13.68	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.77 tender joints Standard Deviation 14.84	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.84 tender joints Standard Deviation 12.79	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.83 tender joints Standard Deviation 9.61	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.09 tender joints Standard Deviation 11.65	10.88 tender joints Standard Deviation 12.79	10.18 tender joints Standard Deviation 12.65
Tender Joints Count (TJC) Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)	7.07 tender joints Standard Deviation 8.86	26.25 tender joints Standard Deviation 19.07	8.51 tender joints Standard Deviation 7.25	15.56 tender joints Standard Deviation 18.52	8.07 tender joints Standard Deviation 9.11	19.33 tender joints Standard Deviation 15.70	6.02 tender joints Standard Deviation 7.97	19.15 tender joints Standard Deviation 16.42	8.64 tender joints Standard Deviation 12.25	9.77 tender joints Standard Deviation 12.49	8.39 tender joints Standard Deviation 11.32

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	-9.59 tender joints Standard Deviation 10.42	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.03 tender joints Standard Deviation 10.05	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.28 tender joints Standard Deviation 8.68	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.26 tender joints Standard Deviation 9.63	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.42 tender joints Standard Deviation 9.73	-10.77 tender joints Standard Deviation 10.25	-10.90 tender joints Standard Deviation 11.13
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	-10.58 tender joints Standard Deviation 9.60	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.69 tender joints Standard Deviation 11.68	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.86 tender joints Standard Deviation 10.26	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.78 tender joints Standard Deviation 10.82	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.01 tender joints Standard Deviation 9.64	-11.07 tender joints Standard Deviation 9.94	-12.14 tender joints Standard Deviation 10.07
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	-12.26 tender joints Standard Deviation 9.96	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.03 tender joints Standard Deviation 13.26	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.08 tender joints Standard Deviation 10.79	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.69 tender joints Standard Deviation 11.57	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.50 tender joints Standard Deviation 9.06	-11.93 tender joints Standard Deviation 10.92	-13.76 tender joints Standard Deviation 11.73
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)	-12.77 tender joints Standard Deviation 10.92	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.84 tender joints Standard Deviation 12.84	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.67 tender joints Standard Deviation 10.73	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-14.00 tender joints Standard Deviation 12.56	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.88 tender joints Standard Deviation 11.01	-13.47 tender joints Standard Deviation 9.96	-14.24 tender joints Standard Deviation 11.80
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,21,44,13,55,64,60,53,12,36,17)	-16.36 tender joints Standard Deviation 10.60	-6.92 tender joints Standard Deviation 12.62	-13.17 tender joints Standard Deviation 9.90	-7.59 tender joints Standard Deviation 12.39	-14.53 tender joints Standard Deviation 10.83	-10.40 tender joints Standard Deviation 11.27	-18.16 tender joints Standard Deviation 9.82	-6.23 tender joints Standard Deviation 10.54	-14.93 tender joints Standard Deviation 11.72	-16.36 tender joints Standard Deviation 9.39	-17.03 tender joints Standard Deviation 10.39
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	-7.78 tender joints Standard Deviation 9.67	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.27 tender joints Standard Deviation 7.50	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.68 tender joints Standard Deviation 7.26	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.09 tender joints Standard Deviation 9.91	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.06 tender joints Standard Deviation 9.36	-7.62 tender joints Standard Deviation 8.48	-7.68 tender joints Standard Deviation 10.20
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)	-15.65 tender joints Standard Deviation 9.29	-2.33 tender joints Standard Deviation 15.69	-10.16 tender joints Standard Deviation 9.92	-8.06 tender joints Standard Deviation 10.88	-14.05 tender joints Standard Deviation 9.97	-6.81 tender joints Standard Deviation 7.90	-17.44 tender joints Standard Deviation 10.54	-1.00 tender joints Standard Deviation 14.29	-12.93 tender joints Standard Deviation 12.63	-14.58 tender joints Standard Deviation 11.19	-15.05 tender joints Standard Deviation 11.31
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	-15.67 tender joints Standard Deviation 9.33	-5.58 tender joints Standard Deviation 11.32	-11.05 tender joints Standard Deviation 11.86	-8.24 tender joints Standard Deviation 11.19	-13.64 tender joints Standard Deviation 10.63	-12.38 tender joints Standard Deviation 10.61	-18.36 tender joints Standard Deviation 9.52	-5.15 tender joints Standard Deviation 11.07	-14.58 tender joints Standard Deviation 11.94	-16.08 tender joints Standard Deviation 10.43	-16.64 tender joints Standard Deviation 10.73

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Swollen Joints Count (SJC) Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	10.14 swollen joints Standard Deviation 6.26	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.41 swollen joints Standard Deviation 9.47	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.62 swollen joints Standard Deviation 7.81	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.97 swollen joints Standard Deviation 9.02	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.51 swollen joints Standard Deviation 6.30	10.14 swollen joints Standard Deviation 7.92	10.07 swollen joints Standard Deviation 7.29
Swollen Joints Count (SJC) Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	8.61 swollen joints Standard Deviation 7.16	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.11 swollen joints Standard Deviation 8.58	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.85 swollen joints Standard Deviation 7.74	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.58 swollen joints Standard Deviation 8.20	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.01 swollen joints Standard Deviation 7.45	7.53 swollen joints Standard Deviation 6.98	7.85 swollen joints Standard Deviation 6.70
Swollen Joints Count (SJC) Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	7.66 swollen joints Standard Deviation 7.43	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.39 swollen joints Standard Deviation 9.24	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.77 swollen joints Standard Deviation 6.34	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.23 swollen joints Standard Deviation 7.28	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.22 swollen joints Standard Deviation 6.00	7.10 swollen joints Standard Deviation 7.62	6.60 swollen joints Standard Deviation 6.31
Swollen Joints Count (SJC) Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	7.22 swollen joints Standard Deviation 8.60	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.16 swollen joints Standard Deviation 8.02	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.20 swollen joints Standard Deviation 7.84	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.63 swollen joints Standard Deviation 7.63	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.35 swollen joints Standard Deviation 5.03	6.78 swollen joints Standard Deviation 7.43	6.01 swollen joints Standard Deviation 6.22
Swollen Joints Count (SJC) Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	3.31 swollen joints Standard Deviation 4.19	12.25 swollen joints Standard Deviation 8.25	5.00 swollen joints Standard Deviation 6.65	7.41 swollen joints Standard Deviation 9.27	4.95 swollen joints Standard Deviation 7.82	7.33 swollen joints Standard Deviation 8.75	3.36 swollen joints Standard Deviation 5.19	8.54 swollen joints Standard Deviation 9.85	3.95 swollen joints Standard Deviation 5.80	4.21 swollen joints Standard Deviation 5.59	3.27 swollen joints Standard Deviation 4.02
Swollen Joints Count (SJC) Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)	2.89 swollen joints Standard Deviation 2.97	11.25 swollen joints Standard Deviation 9.81	4.11 swollen joints Standard Deviation 3.90	7.94 swollen joints Standard Deviation 8.90	4.10 swollen joints Standard Deviation 4.83	8.65 swollen joints Standard Deviation 8.77	3.73 swollen joints Standard Deviation 5.35	7.00 swollen joints Standard Deviation 7.14	3.71 swollen joints Standard Deviation 4.33	4.41 swollen joints Standard Deviation 6.86	3.03 swollen joints Standard Deviation 3.75
Swollen Joints Count (SJC) Baseline (n=70,0,68,0,71,74,75,80,0,69,0)	15.21 swollen joints Standard Deviation 8.04	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.72 swollen joints Standard Deviation 8.83	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.51 swollen joints Standard Deviation 8.24	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.68 swollen joints Standard Deviation 8.56	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.06 swollen joints Standard Deviation 7.44	14.74 swollen joints Standard Deviation 7.46	15.33 swollen joints Standard Deviation 7.02
Swollen Joints Count (SJC) Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)	6.80 swollen joints Standard Deviation 8.87	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.79 swollen joints Standard Deviation 9.10	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.31 swollen joints Standard Deviation 8.41	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.36 swollen joints Standard Deviation 6.64	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.13 swollen joints Standard Deviation 6.82	5.50 swollen joints Standard Deviation 5.84	4.85 swollen joints Standard Deviation 6.04
Swollen Joints Count (SJC) Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)	3.58 swollen joints Standard Deviation 3.54	14.50 swollen joints Standard Deviation 12.99	5.97 swollen joints Standard Deviation 5.98	8.63 swollen joints Standard Deviation 7.70	5.83 swollen joints Standard Deviation 7.43	8.90 swollen joints Standard Deviation 7.55	3.49 swollen joints Standard Deviation 3.78	10.00 swollen joints Standard Deviation 10.51	3.84 swollen joints Standard Deviation 4.40	4.74 swollen joints Standard Deviation 5.64	4.26 swollen joints Standard Deviation 5.40

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	-5.04 swollen joints Standard Deviation 7.45	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.12 swollen joints Standard Deviation 5.00	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.43 swollen joints Standard Deviation 5.98	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.71 swollen joints Standard Deviation 7.40	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.24 swollen joints Standard Deviation 6.33	-4.75 swollen joints Standard Deviation 5.57	-5.45 swollen joints Standard Deviation 7.74
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	-6.74 swollen joints Standard Deviation 8.13	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.56 swollen joints Standard Deviation 5.61	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.19 swollen joints Standard Deviation 6.50	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.25 swollen joints Standard Deviation 8.80	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.97 swollen joints Standard Deviation 5.44	-7.34 swollen joints Standard Deviation 6.27	-7.64 swollen joints Standard Deviation 6.77
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	-7.97 swollen joints Standard Deviation 7.54	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.48 swollen joints Standard Deviation 6.91	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.41 swollen joints Standard Deviation 6.58	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.42 swollen joints Standard Deviation 9.28	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.68 swollen joints Standard Deviation 6.30	-7.68 swollen joints Standard Deviation 7.35	-8.68 swollen joints Standard Deviation 6.73
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	-8.26 swollen joints Standard Deviation 8.30	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.15 swollen joints Standard Deviation 6.82	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.80 swollen joints Standard Deviation 8.13	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.03 swollen joints Standard Deviation 9.79	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.74 swollen joints Standard Deviation 6.94	-8.06 swollen joints Standard Deviation 7.40	-9.31 swollen joints Standard Deviation 7.51
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)	-10.65 swollen joints Standard Deviation 7.09	-5.83 swollen joints Standard Deviation 13.62	-8.65 swollen joints Standard Deviation 6.58	-6.88 swollen joints Standard Deviation 6.51	-10.67 swollen joints Standard Deviation 8.78	-5.95 swollen joints Standard Deviation 6.99	-13.00 swollen joints Standard Deviation 8.90	-2.46 swollen joints Standard Deviation 5.77	-10.60 swollen joints Standard Deviation 7.43	-9.95 swollen joints Standard Deviation 6.97	-10.66 swollen joints Standard Deviation 6.75
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	-11.00 swollen joints Standard Deviation 6.99	-8.08 swollen joints Standard Deviation 9.89	-9.62 swollen joints Standard Deviation 7.31	-7.88 swollen joints Standard Deviation 9.21	-10.95 swollen joints Standard Deviation 8.32	-7.52 swollen joints Standard Deviation 8.20	-13.36 swollen joints Standard Deviation 8.25	-3.92 swollen joints Standard Deviation 5.72	-10.39 swollen joints Standard Deviation 6.98	-10.48 swollen joints Standard Deviation 7.21	-11.61 swollen joints Standard Deviation 6.35
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)	-11.57 swollen joints Standard Deviation 7.50	-9.08 swollen joints Standard Deviation 11.99	-10.28 swollen joints Standard Deviation 7.46	-7.35 swollen joints Standard Deviation 6.47	-12.15 swollen joints Standard Deviation 7.83	-6.60 swollen joints Standard Deviation 7.50	-13.00 swollen joints Standard Deviation 8.52	-5.46 swollen joints Standard Deviation 6.77	-10.25 swollen joints Standard Deviation 6.70	-10.48 swollen joints Standard Deviation 6.33	-11.70 swollen joints Standard Deviation 6.38
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)	-8.84 swollen joints Standard Deviation 8.48	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.52 swollen joints Standard Deviation 8.28	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.61 swollen joints Standard Deviation 9.15	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.47 swollen joints Standard Deviation 9.71	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.13 swollen joints Standard Deviation 8.00	-9.20 swollen joints Standard Deviation 7.16	-10.68 swollen joints Standard Deviation 7.37

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=67 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Patient Assessment of Arthritis Pain Week 12 (n=64,0,59,0,64,65,66,70,0,61,0)	31.09 mm Standard Deviation 26.57	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.02 mm Standard Deviation 26.13	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.92 mm Standard Deviation 22.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.90 mm Standard Deviation 24.44	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.88 mm Standard Deviation 22.80	33.78 mm Standard Deviation 25.50	31.48 mm Standard Deviation 24.86
Patient Assessment of Arthritis Pain Baseline (n=70,0,66,0,71,74,75,80,0,69,0)	59.61 mm Standard Deviation 23.61	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.19 mm Standard Deviation 27.72	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	59.96 mm Standard Deviation 25.67	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	55.05 mm Standard Deviation 24.81	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.87 mm Standard Deviation 26.68	56.66 mm Standard Deviation 25.42	55.83 mm Standard Deviation 22.85
Patient Assessment of Arthritis Pain Week 2 (n=68,0,67,0,68,73,73,79,0,66,0)	40.57 mm Standard Deviation 27.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.91 mm Standard Deviation 25.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.53 mm Standard Deviation 24.99	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.33 mm Standard Deviation 23.26	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.35 mm Standard Deviation 24.31	41.26 mm Standard Deviation 22.18	37.82 mm Standard Deviation 22.17
Patient Assessment of Arthritis Pain Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	34.39 mm Standard Deviation 24.29	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.02 mm Standard Deviation 24.40	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.57 mm Standard Deviation 24.99	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.83 mm Standard Deviation 22.77	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.03 mm Standard Deviation 24.25	39.34 mm Standard Deviation 25.09	35.81 mm Standard Deviation 23.88
Patient Assessment of Arthritis Pain Week 6 (n=66,0,65,0,69,71,72,74,0,61,0)	33.65 mm Standard Deviation 25.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.21 mm Standard Deviation 27.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.74 mm Standard Deviation 24.31	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.75 mm Standard Deviation 25.06	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.33 mm Standard Deviation 24.18	34.38 mm Standard Deviation 23.15	32.97 mm Standard Deviation 23.50
Patient Assessment of Arthritis Pain Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	31.16 mm Standard Deviation 24.86	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.34 mm Standard Deviation 26.45	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.97 mm Standard Deviation 23.33	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.81 mm Standard Deviation 23.86	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.55 mm Standard Deviation 25.00	34.60 mm Standard Deviation 24.04	30.26 mm Standard Deviation 22.20
Patient Assessment of Arthritis Pain Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)	24.56 mm Standard Deviation 23.46	51.25 mm Standard Deviation 21.95	30.08 mm Standard Deviation 22.81	38.38 mm Standard Deviation 24.52	27.83 mm Standard Deviation 18.65	40.38 mm Standard Deviation 21.81	29.67 mm Standard Deviation 24.13	39.31 mm Standard Deviation 24.13	28.98 mm Standard Deviation 22.15	30.33 mm Standard Deviation 22.04	27.07 mm Standard Deviation 20.76
Patient Assessment of Arthritis Pain Week 20 (n=39,21,43,13,57,65,59,55,12,37,17)	24.58 mm Standard Deviation 26.24	43.92 mm Standard Deviation 27.07	25.08 mm Standard Deviation 21.19	33.00 mm Standard Deviation 27.70	29.28 mm Standard Deviation 22.75	35.71 mm Standard Deviation 22.42	26.63 mm Standard Deviation 23.48	42.31 mm Standard Deviation 28.61	25.91 mm Standard Deviation 23.10	33.66 mm Standard Deviation 24.02	24.69 mm Standard Deviation 20.98
Patient Assessment of Arthritis Pain Week 24 (n=40,20,44,13,55,63,60,53,12,36,17)	19.92 mm Standard Deviation 18.27	35.33 mm Standard Deviation 27.17	27.14 mm Standard Deviation 21.17	33.65 mm Standard Deviation 26.15	25.53 mm Standard Deviation 21.05	38.15 mm Standard Deviation 26.27	25.98 mm Standard Deviation 20.61	35.62 mm Standard Deviation 28.27	24.45 mm Standard Deviation 20.24	28.65 mm Standard Deviation 21.11	24.47 mm Standard Deviation 22.23

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=65 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,63,0,69,71,72,74,0,61,0)	-26.97 mm Standard Deviation 26.15	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.61 mm Standard Deviation 29.03	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.56 mm Standard Deviation 31.29	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.71 mm Standard Deviation 28.84	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-21.07 mm Standard Deviation 29.07	-22.94 mm Standard Deviation 29.71	-22.61 mm Standard Deviation 28.87
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,60,0,66,67,70,73,0,61,0)	-29.08 mm Standard Deviation 27.13	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.97 mm Standard Deviation 28.48	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.91 mm Standard Deviation 26.68	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-26.23 mm Standard Deviation 29.28	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-18.11 mm Standard Deviation 29.71	-21.84 mm Standard Deviation 30.42	-24.66 mm Standard Deviation 30.16
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=64,0,57,0,64,65,66,70,0,61,0)	-29.67 mm Standard Deviation 28.25	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.30 mm Standard Deviation 30.14	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-23.16 mm Standard Deviation 28.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-24.39 mm Standard Deviation 30.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-25.75 mm Standard Deviation 29.47	-24.02 mm Standard Deviation 27.96	-23.95 mm Standard Deviation 29.90
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,41,13,57,65,59,55,12,37,17)	-32.95 mm Standard Deviation 27.48	-26.33 mm Standard Deviation 33.15	-22.22 mm Standard Deviation 30.68	-21.82 mm Standard Deviation 21.49	-31.54 mm Standard Deviation 36.96	-18.14 mm Standard Deviation 25.06	-32.37 mm Standard Deviation 26.83	-12.15 mm Standard Deviation 25.36	-29.54 mm Standard Deviation 30.99	-22.78 mm Standard Deviation 30.27	-30.97 mm Standard Deviation 31.28
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=65,0,68,0,68,73,73,79,0,66,0)	-18.84 mm Standard Deviation 25.59	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.55 mm Standard Deviation 25.28	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.49 mm Standard Deviation 24.31	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.00 mm Standard Deviation 20.82	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.76 mm Standard Deviation 26.22	-15.30 mm Standard Deviation 25.46	-17.67 mm Standard Deviation 24.58
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,63,0,67,70,72,76,0,66,0)	-24.74 mm Standard Deviation 26.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.26 mm Standard Deviation 28.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.44 mm Standard Deviation 26.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.11 mm Standard Deviation 23.98	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-14.76 mm Standard Deviation 24.06	-17.80 mm Standard Deviation 30.25	-20.39 mm Standard Deviation 28.95
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)	-32.09 mm Standard Deviation 24.84	-19.00 mm Standard Deviation 29.73	-17.22 mm Standard Deviation 35.13	-18.19 mm Standard Deviation 21.36	-34.02 mm Standard Deviation 31.75	-13.48 mm Standard Deviation 25.66	-27.19 mm Standard Deviation 24.93	-15.15 mm Standard Deviation 21.97	-26.50 mm Standard Deviation 28.81	-26.64 mm Standard Deviation 25.04	-27.97 mm Standard Deviation 29.32
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,20,42,13,55,63,60,53,12,36,17)	-36.98 mm Standard Deviation 27.86	-34.92 mm Standard Deviation 31.74	-21.08 mm Standard Deviation 32.99	-21.18 mm Standard Deviation 26.30	-36.08 mm Standard Deviation 32.62	-15.40 mm Standard Deviation 24.78	-33.19 mm Standard Deviation 25.68	-18.85 mm Standard Deviation 24.73	-29.89 mm Standard Deviation 30.87	-28.51 mm Standard Deviation 28.01	-31.00 mm Standard Deviation 31.88

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Patient Global Assessment (PtGA) of Arthritis Baseline (n=70,0,68,0,71,74,75,79,0,69,0)	57.24 mm Standard Deviation 25.64	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.88 mm Standard Deviation 26.44	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.47 mm Standard Deviation 24.77	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	58.91 mm Standard Deviation 22.94	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.62 mm Standard Deviation 23.71	58.35 mm Standard Deviation 23.14	56.09 mm Standard Deviation 21.42
Patient Global Assessment (PtGA) of Arthritis Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	41.80 mm Standard Deviation 26.25	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.33 mm Standard Deviation 25.02	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	53.19 mm Standard Deviation 22.93	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.96 mm Standard Deviation 23.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.56 mm Standard Deviation 22.89	42.32 mm Standard Deviation 21.98	35.73 mm Standard Deviation 21.46
Patient Global Assessment (PtGA) of Arthritis Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	31.85 mm Standard Deviation 25.35	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.64 mm Standard Deviation 25.32	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.06 mm Standard Deviation 21.76	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.11 mm Standard Deviation 22.38	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.50 mm Standard Deviation 25.29	36.09 mm Standard Deviation 24.38	30.61 mm Standard Deviation 21.60
Patient Global Assessment (PtGA) of Arthritis Week 12 (n=64,0,59,0,64,65,66,70,0,60,0)	30.76 mm Standard Deviation 25.59	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.85 mm Standard Deviation 25.75	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.78 mm Standard Deviation 22.91	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.42 mm Standard Deviation 25.15	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.66 mm Standard Deviation 21.69	35.05 mm Standard Deviation 24.65	32.53 mm Standard Deviation 24.48
Patient Global Assessment (PtGA) of Arthritis Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)	24.76 mm Standard Deviation 22.53	50.67 mm Standard Deviation 23.10	28.46 mm Standard Deviation 22.69	37.63 mm Standard Deviation 23.11	30.76 mm Standard Deviation 20.40	38.29 mm Standard Deviation 19.76	29.84 mm Standard Deviation 24.12	39.31 mm Standard Deviation 27.48	30.62 mm Standard Deviation 22.56	30.98 mm Standard Deviation 22.06	26.59 mm Standard Deviation 20.19
Patient Global Assessment (PtGA) of Arthritis Week 20 (n=39,21,43,13,57,66,59,55,12,37,17)	25.56 mm Standard Deviation 23.20	44.42 mm Standard Deviation 27.38	26.22 mm Standard Deviation 21.09	36.94 mm Standard Deviation 27.13	29.85 mm Standard Deviation 22.86	37.95 mm Standard Deviation 23.62	28.16 mm Standard Deviation 22.36	42.08 mm Standard Deviation 27.48	26.07 mm Standard Deviation 22.75	35.00 mm Standard Deviation 23.51	24.90 mm Standard Deviation 20.57
Patient Global Assessment (PtGA) of Arthritis Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)	37.47 mm Standard Deviation 25.17	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.21 mm Standard Deviation 24.46	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.87 mm Standard Deviation 23.21	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.78 mm Standard Deviation 22.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.94 mm Standard Deviation 22.27	38.53 mm Standard Deviation 24.49	34.76 mm Standard Deviation 21.33
Patient Global Assessment (PtGA) of Arthritis Week 6 (n=66,0,65,0,69,71,72,74,0,61,0)	34.86 mm Standard Deviation 25.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.02 mm Standard Deviation 25.14	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.30 mm Standard Deviation 22.34	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.08 mm Standard Deviation 23.56	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.01 mm Standard Deviation 24.06	35.41 mm Standard Deviation 22.68	30.56 mm Standard Deviation 21.87
Patient Global Assessment (PtGA) of Arthritis Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)	21.85 mm Standard Deviation 18.07	34.83 mm Standard Deviation 27.04	28.25 mm Standard Deviation 21.49	34.59 mm Standard Deviation 27.87	28.23 mm Standard Deviation 21.42	38.55 mm Standard Deviation 27.08	25.93 mm Standard Deviation 22.22	38.23 mm Standard Deviation 27.28	23.64 mm Standard Deviation 21.82	29.66 mm Standard Deviation 21.58	25.07 mm Standard Deviation 23.20

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Outcome measures

Measure	CP-690,550 20 mg n=78 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,65,0,69,71,72,73,0,61,0)	-22.99 mm Standard Deviation 29.63	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.46 mm Standard Deviation 23.90	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-18.71 mm Standard Deviation 29.02	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.02 mm Standard Deviation 25.83	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.81 mm Standard Deviation 24.06	-24.03 mm Standard Deviation 23.89	-25.26 mm Standard Deviation 30.85
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,62,0,66,67,70,72,0,61,0)	-25.92 mm Standard Deviation 30.55	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.48 mm Standard Deviation 25.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.35 mm Standard Deviation 27.84	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-27.48 mm Standard Deviation 26.13	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.44 mm Standard Deviation 28.12	-22.58 mm Standard Deviation 25.37	-24.81 mm Standard Deviation 31.07
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=64,0,59,0,64,65,66,69,0,60,0)	-28.09 mm Standard Deviation 30.23	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.75 mm Standard Deviation 28.20	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.78 mm Standard Deviation 28.81	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-23.95 mm Standard Deviation 29.82	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-24.30 mm Standard Deviation 24.57	-24.77 mm Standard Deviation 26.21	-23.08 mm Standard Deviation 30.87
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,45,13,58,66,61,53,12,37,16)	-29.68 mm Standard Deviation 31.20	-13.67 mm Standard Deviation 35.93	-20.97 mm Standard Deviation 31.57	-14.81 mm Standard Deviation 17.72	-33.60 mm Standard Deviation 31.45	-15.86 mm Standard Deviation 22.28	-28.00 mm Standard Deviation 28.15	-22.00 mm Standard Deviation 26.01	-24.05 mm Standard Deviation 28.00	-27.97 mm Standard Deviation 24.02	-28.90 mm Standard Deviation 29.36
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,43,13,57,66,59,54,12,36,17)	-30.67 mm Standard Deviation 31.38	-19.92 mm Standard Deviation 34.52	-23.22 mm Standard Deviation 27.31	-13.53 mm Standard Deviation 22.22	-34.56 mm Standard Deviation 31.99	-16.19 mm Standard Deviation 24.18	-30.93 mm Standard Deviation 25.67	-19.23 mm Standard Deviation 28.78	-28.33 mm Standard Deviation 26.93	-23.95 mm Standard Deviation 27.82	-31.12 mm Standard Deviation 32.09
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)	-33.04 mm Standard Deviation 32.02	-29.50 mm Standard Deviation 32.33	-21.92 mm Standard Deviation 27.51	-15.88 mm Standard Deviation 25.95	-36.68 mm Standard Deviation 29.89	-15.30 mm Standard Deviation 32.99	-32.11 mm Standard Deviation 25.76	-23.08 mm Standard Deviation 31.06	-29.84 mm Standard Deviation 27.59	-28.61 mm Standard Deviation 25.31	-30.83 mm Standard Deviation 32.96
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=68,0,68,0,68,73,73,78,0,66,0)	-15.38 mm Standard Deviation 30.86	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.82 mm Standard Deviation 24.96	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.57 mm Standard Deviation 26.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.96 mm Standard Deviation 20.11	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.37 mm Standard Deviation 21.83	-16.74 mm Standard Deviation 24.15	-20.25 mm Standard Deviation 26.92
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)	-19.04 mm Standard Deviation 29.28	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.65 mm Standard Deviation 27.81	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.90 mm Standard Deviation 25.53	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.40 mm Standard Deviation 25.40	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.70 mm Standard Deviation 22.92	-20.76 mm Standard Deviation 26.76	-21.82 mm Standard Deviation 28.55

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Physician Global Assessment of Arthritis Baseline (n=70,0,68,0,71,74,75,80,0,69,0)	58.75 mm Standard Deviation 17.90	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	58.30 mm Standard Deviation 15.25	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.66 mm Standard Deviation 16.00	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	57.50 mm Standard Deviation 18.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	56.51 mm Standard Deviation 19.00	60.77 mm Standard Deviation 16.75	60.51 mm Standard Deviation 14.26
Physician Global Assessment of Arthritis Week 2 (n=67,0,68,0,68,73,73,79,0,66,0)	41.92 mm Standard Deviation 22.30	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.05 mm Standard Deviation 18.00	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.49 mm Standard Deviation 21.64	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.07 mm Standard Deviation 19.88	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.29 mm Standard Deviation 20.12	42.85 mm Standard Deviation 19.42	35.99 mm Standard Deviation 15.97
Physician Global Assessment of Arthritis Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	32.65 mm Standard Deviation 23.41	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.85 mm Standard Deviation 21.03	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.38 mm Standard Deviation 17.11	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.51 mm Standard Deviation 21.25	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.78 mm Standard Deviation 18.40	30.82 mm Standard Deviation 19.95	27.08 mm Standard Deviation 17.28
Physician Global Assessment of Arthritis Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	27.70 mm Standard Deviation 21.09	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.66 mm Standard Deviation 21.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.71 mm Standard Deviation 21.03	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.60 mm Standard Deviation 20.34	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.26 mm Standard Deviation 19.97	28.01 mm Standard Deviation 19.90	23.06 mm Standard Deviation 17.18
Physician Global Assessment of Arthritis Week 12 (n=63,0,59,0,64,66,65,70,0,61,0)	28.93 mm Standard Deviation 23.44	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.70 mm Standard Deviation 24.86	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.65 mm Standard Deviation 20.06	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.17 mm Standard Deviation 21.33	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.77 mm Standard Deviation 18.80	26.47 mm Standard Deviation 19.69	23.28 mm Standard Deviation 17.89
Physician Global Assessment of Arthritis Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)	18.60 mm Standard Deviation 15.00	48.42 mm Standard Deviation 30.00	26.22 mm Standard Deviation 18.43	27.44 mm Standard Deviation 16.36	23.95 mm Standard Deviation 16.25	44.19 mm Standard Deviation 24.68	19.77 mm Standard Deviation 19.74	33.31 mm Standard Deviation 22.97	23.67 mm Standard Deviation 21.04	23.00 mm Standard Deviation 18.60	19.31 mm Standard Deviation 15.80
Physician Global Assessment of Arthritis Week 24 (n=40,19,43,13,55,64,60,53,11,36,17)	14.49 mm Standard Deviation 11.75	41.00 mm Standard Deviation 31.58	20.67 mm Standard Deviation 15.81	32.18 mm Standard Deviation 19.03	18.90 mm Standard Deviation 16.51	36.53 mm Standard Deviation 21.17	20.26 mm Standard Deviation 18.12	32.54 mm Standard Deviation 24.26	16.91 mm Standard Deviation 14.67	21.25 mm Standard Deviation 17.79	14.68 mm Standard Deviation 13.07
Physician Global Assessment of Arthritis Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)	32.96 mm Standard Deviation 22.38	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.23 mm Standard Deviation 19.43	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.69 mm Standard Deviation 21.31	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.92 mm Standard Deviation 21.20	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.73 mm Standard Deviation 17.40	33.56 mm Standard Deviation 19.77	33.35 mm Standard Deviation 19.24
Physician Global Assessment of Arthritis Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	18.84 mm Standard Deviation 18.42	44.67 mm Standard Deviation 25.31	21.95 mm Standard Deviation 18.03	33.94 mm Standard Deviation 22.43	20.44 mm Standard Deviation 18.10	34.29 mm Standard Deviation 16.64	20.91 mm Standard Deviation 18.21	32.92 mm Standard Deviation 25.15	20.65 mm Standard Deviation 18.68	24.05 mm Standard Deviation 18.32	16.19 mm Standard Deviation 12.41

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=68 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=67 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=67,0,68,0,68,73,73,79,0,66,0)	-16.61 mm Standard Deviation 19.17	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.82 mm Standard Deviation 13.20	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.88 mm Standard Deviation 17.84	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.43 mm Standard Deviation 19.20	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-14.60 mm Standard Deviation 24.01	-17.88 mm Standard Deviation 17.66	-24.30 mm Standard Deviation 18.32
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)	-25.31 mm Standard Deviation 22.01	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.79 mm Standard Deviation 18.95	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.66 mm Standard Deviation 19.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.80 mm Standard Deviation 22.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.00 mm Standard Deviation 20.79	-27.67 mm Standard Deviation 20.61	-27.43 mm Standard Deviation 21.04
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)	-25.93 mm Standard Deviation 23.04	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.15 mm Standard Deviation 22.19	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-25.02 mm Standard Deviation 20.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-26.34 mm Standard Deviation 24.05	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-28.80 mm Standard Deviation 20.44	-30.39 mm Standard Deviation 20.61	-33.26 mm Standard Deviation 19.40
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)	-30.66 mm Standard Deviation 21.10	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.82 mm Standard Deviation 22.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-26.50 mm Standard Deviation 22.83	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-30.92 mm Standard Deviation 22.85	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-29.67 mm Standard Deviation 24.30	-33.63 mm Standard Deviation 21.96	-37.26 mm Standard Deviation 19.37
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=63,0,59,0,64,66,66,70,0,61,0)	-30.27 mm Standard Deviation 22.44	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-21.77 mm Standard Deviation 24.51	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-28.76 mm Standard Deviation 23.50	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-31.69 mm Standard Deviation 24.30	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-31.58 mm Standard Deviation 23.09	-34.98 mm Standard Deviation 20.53	-36.80 mm Standard Deviation 20.78
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)	-38.65 mm Standard Deviation 17.68	-19.08 mm Standard Deviation 29.20	-29.89 mm Standard Deviation 22.16	-32.56 mm Standard Deviation 15.65	-39.33 mm Standard Deviation 19.85	-16.95 mm Standard Deviation 26.42	-39.23 mm Standard Deviation 23.11	-23.85 mm Standard Deviation 19.42	-33.47 mm Standard Deviation 26.06	-38.45 mm Standard Deviation 20.53	-39.70 mm Standard Deviation 20.34
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	-38.16 mm Standard Deviation 19.33	-22.83 mm Standard Deviation 26.51	-34.16 mm Standard Deviation 23.25	-26.29 mm Standard Deviation 24.43	-42.21 mm Standard Deviation 23.73	-26.86 mm Standard Deviation 23.81	-38.70 mm Standard Deviation 20.41	-24.23 mm Standard Deviation 22.29	-36.81 mm Standard Deviation 24.26	-37.41 mm Standard Deviation 18.99	-43.42 mm Standard Deviation 16.85
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,19,43,13,55,64,60,53,11,36,17)	-41.91 mm Standard Deviation 17.09	-28.64 mm Standard Deviation 31.29	-35.06 mm Standard Deviation 21.26	-28.06 mm Standard Deviation 20.84	-44.15 mm Standard Deviation 22.39	-24.11 mm Standard Deviation 24.91	-39.98 mm Standard Deviation 21.13	-24.62 mm Standard Deviation 19.99	-39.51 mm Standard Deviation 22.83	-40.61 mm Standard Deviation 20.10	-44.65 mm Standard Deviation 16.76

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

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

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=66 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline (n=70,0,66,0,71,74,75,80,0,69,0)	1.46 units on a scale Standard Deviation 0.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.20 units on a scale Standard Deviation 0.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.58 units on a scale Standard Deviation 0.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.36 units on a scale Standard Deviation 0.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.44 units on a scale Standard Deviation 0.64	1.33 units on a scale Standard Deviation 0.60	1.41 units on a scale Standard Deviation 0.64
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	1.23 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.15 units on a scale Standard Deviation 0.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.41 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.14 units on a scale Standard Deviation 0.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.20 units on a scale Standard Deviation 0.58	1.16 units on a scale Standard Deviation 0.61	1.15 units on a scale Standard Deviation 0.67
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)	1.14 units on a scale Standard Deviation 0.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.14 units on a scale Standard Deviation 0.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.32 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.03 units on a scale Standard Deviation 0.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.13 units on a scale Standard Deviation 0.65	1.08 units on a scale Standard Deviation 0.64	1.12 units on a scale Standard Deviation 0.69
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 8 (n=66,0,62,0,66,67,70,71,0,61,0)	0.98 units on a scale Standard Deviation 0.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.05 units on a scale Standard Deviation 0.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.22 units on a scale Standard Deviation 0.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.93 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.06 units on a scale Standard Deviation 0.66	0.89 units on a scale Standard Deviation 0.67	0.98 units on a scale Standard Deviation 0.68
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 12 (n=64,0,59,0,64,65,66,68,0,61,0)	0.90 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.08 units on a scale Standard Deviation 0.74	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.19 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.92 units on a scale Standard Deviation 0.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.94 units on a scale Standard Deviation 0.65	0.95 units on a scale Standard Deviation 0.68	0.96 units on a scale Standard Deviation 0.69
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)	0.81 units on a scale Standard Deviation 0.67	1.36 units on a scale Standard Deviation 0.67	0.80 units on a scale Standard Deviation 0.64	1.05 units on a scale Standard Deviation 0.80	1.05 units on a scale Standard Deviation 0.59	1.42 units on a scale Standard Deviation 0.64	0.82 units on a scale Standard Deviation 0.72	1.18 units on a scale Standard Deviation 0.77	0.92 units on a scale Standard Deviation 0.60	0.91 units on a scale Standard Deviation 0.68	0.97 units on a scale Standard Deviation 0.75
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)	0.75 units on a scale Standard Deviation 0.63	1.42 units on a scale Standard Deviation 0.62	0.73 units on a scale Standard Deviation 0.65	0.92 units on a scale Standard Deviation 0.75	0.95 units on a scale Standard Deviation 0.58	1.33 units on a scale Standard Deviation 0.72	0.77 units on a scale Standard Deviation 0.68	1.13 units on a scale Standard Deviation 0.78	0.78 units on a scale Standard Deviation 0.57	0.84 units on a scale Standard Deviation 0.65	0.92 units on a scale Standard Deviation 0.72
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 24 (n=40,20,44,13,54,63,59,53,12,36,17)	0.72 units on a scale Standard Deviation 0.61	1.34 units on a scale Standard Deviation 0.78	0.74 units on a scale Standard Deviation 0.66	0.95 units on a scale Standard Deviation 0.68	0.99 units on a scale Standard Deviation 0.57	1.38 units on a scale Standard Deviation 0.74	0.85 units on a scale Standard Deviation 0.68	1.05 units on a scale Standard Deviation 0.84	0.78 units on a scale Standard Deviation 0.62	0.85 units on a scale Standard Deviation 0.66	0.88 units on a scale Standard Deviation 0.69
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 6 (n=66,0,64,0,69,71,72,74,0,61,0)	1.05 units on a scale Standard Deviation 0.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.07 units on a scale Standard Deviation 0.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.23 units on a scale Standard Deviation 0.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.96 units on a scale Standard Deviation 0.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.03 units on a scale Standard Deviation 0.61	1.02 units on a scale Standard Deviation 0.65	1.05 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

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. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=66 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=66,0,61,0,66,67,70,71,0,61,0)	-0.50 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.12 units on a scale Standard Deviation 0.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.34 units on a scale Standard Deviation 0.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.41 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.40 units on a scale Standard Deviation 0.58	-0.43 units on a scale Standard Deviation 0.66	-0.39 units on a scale Standard Deviation 0.49
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,43,13,57,66,59,55,12,37,17)	-0.67 units on a scale Standard Deviation 0.65	-0.41 units on a scale Standard Deviation 0.55	-0.38 units on a scale Standard Deviation 0.54	-0.11 units on a scale Standard Deviation 0.30	-0.62 units on a scale Standard Deviation 0.47	-0.24 units on a scale Standard Deviation 0.42	-0.62 units on a scale Standard Deviation 0.68	-0.13 units on a scale Standard Deviation 0.41	-0.64 units on a scale Standard Deviation 0.62	-0.49 units on a scale Standard Deviation 0.58	-0.51 units on a scale Standard Deviation 0.59
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)	-0.23 units on a scale Standard Deviation 0.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.05 units on a scale Standard Deviation 0.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.15 units on a scale Standard Deviation 0.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.23 units on a scale Standard Deviation 0.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.23 units on a scale Standard Deviation 0.41	-0.18 units on a scale Standard Deviation 0.42	-0.24 units on a scale Standard Deviation 0.40
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=68,0,63,0,67,70,72,75,0,66,0)	-0.34 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.05 units on a scale Standard Deviation 0.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.24 units on a scale Standard Deviation 0.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.36 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.32 units on a scale Standard Deviation 0.51	-0.25 units on a scale Standard Deviation 0.45	-0.31 units on a scale Standard Deviation 0.44
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=66,0,62,0,69,71,72,74,0,61,0)	-0.42 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.13 units on a scale Standard Deviation 0.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.31 units on a scale Standard Deviation 0.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.39 units on a scale Standard Deviation 0.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.42 units on a scale Standard Deviation 0.54	-0.32 units on a scale Standard Deviation 0.57	-0.34 units on a scale Standard Deviation 0.47
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=64,0,58,0,64,65,66,68,0,61,0)	-0.58 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.10 units on a scale Standard Deviation 0.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.37 units on a scale Standard Deviation 0.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.48 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.51 units on a scale Standard Deviation 0.61	-0.37 units on a scale Standard Deviation 0.63	-0.45 units on a scale Standard Deviation 0.50
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)	-0.62 units on a scale Standard Deviation 0.62	-0.46 units on a scale Standard Deviation 0.58	-0.30 units on a scale Standard Deviation 0.52	-0.01 units on a scale Standard Deviation 0.29	-0.52 units on a scale Standard Deviation 0.48	-0.16 units on a scale Standard Deviation 0.50	-0.59 units on a scale Standard Deviation 0.64	-0.08 units on a scale Standard Deviation 0.31	-0.52 units on a scale Standard Deviation 0.59	-0.41 units on a scale Standard Deviation 0.63	-0.45 units on a scale Standard Deviation 0.60
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=40,20,42,13,54,63,59,53,12,36,17)	-0.66 units on a scale Standard Deviation 0.72	-0.48 units on a scale Standard Deviation 0.74	-0.37 units on a scale Standard Deviation 0.54	-0.08 units on a scale Standard Deviation 0.29	-0.60 units on a scale Standard Deviation 0.52	-0.21 units on a scale Standard Deviation 0.58	-0.53 units on a scale Standard Deviation 0.65	-0.21 units on a scale Standard Deviation 0.32	-0.61 units on a scale Standard Deviation 0.65	-0.47 units on a scale Standard Deviation 0.62	-0.53 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
C-Reactive Protein (CRP) Baseline (n=70,0,68,0,71,74,75,80,0,69,0)	14.68 mg/dL Standard Deviation 17.19	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.88 mg/dL Standard Deviation 19.55	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.30 mg/dL Standard Deviation 18.08	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.85 mg/dL Standard Deviation 19.34	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.03 mg/dL Standard Deviation 24.96	14.42 mg/dL Standard Deviation 17.81	17.21 mg/dL Standard Deviation 16.94
C-Reactive Protein (CRP) Week 2 (n=65,0,63,0,63,69,68,74,0,61,0)	8.35 mg/dL Standard Deviation 13.48	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.10 mg/dL Standard Deviation 20.41	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.54 mg/dL Standard Deviation 19.53	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.20 mg/dL Standard Deviation 11.77	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.98 mg/dL Standard Deviation 10.05	5.24 mg/dL Standard Deviation 9.59	4.08 mg/dL Standard Deviation 4.79
C-Reactive Protein (CRP) Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)	8.67 mg/dL Standard Deviation 13.62	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.30 mg/dL Standard Deviation 16.85	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.28 mg/dL Standard Deviation 11.83	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.11 mg/dL Standard Deviation 15.29	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.63 mg/dL Standard Deviation 12.54	5.46 mg/dL Standard Deviation 9.76	4.63 mg/dL Standard Deviation 8.68
C-Reactive Protein (CRP) Week 6 (n=64,0,61,0,66,67,66,69,0,58,0)	10.68 mg/dL Standard Deviation 17.49	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.18 mg/dL Standard Deviation 19.32	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.55 mg/dL Standard Deviation 9.79	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.34 mg/dL Standard Deviation 13.70	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.26 mg/dL Standard Deviation 14.30	5.42 mg/dL Standard Deviation 10.04	5.41 mg/dL Standard Deviation 8.63
C-Reactive Protein (CRP) Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)	9.75 mg/dL Standard Deviation 18.92	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.38 mg/dL Standard Deviation 30.37	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.62 mg/dL Standard Deviation 11.78	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.64 mg/dL Standard Deviation 11.54	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.17 mg/dL Standard Deviation 11.47	10.18 mg/dL Standard Deviation 24.04	8.39 mg/dL Standard Deviation 11.39
C-Reactive Protein (CRP) Week 12 (n=61,0,57,0,60,63,62,65,0,60,0)	9.53 mg/dL Standard Deviation 15.08	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.69 mg/dL Standard Deviation 20.07	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.53 mg/dL Standard Deviation 9.59	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.54 mg/dL Standard Deviation 13.52	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.54 mg/dL Standard Deviation 9.68	9.11 mg/dL Standard Deviation 20.08	5.81 mg/dL Standard Deviation 7.25
C-Reactive Protein (CRP) Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)	6.52 mg/dL Standard Deviation 11.33	6.89 mg/dL Standard Deviation 7.06	13.08 mg/dL Standard Deviation 11.49	6.52 mg/dL Standard Deviation 7.30	7.80 mg/dL Standard Deviation 10.30	7.02 mg/dL Standard Deviation 8.51	10.72 mg/dL Standard Deviation 18.93	5.85 mg/dL Standard Deviation 5.47	5.40 mg/dL Standard Deviation 8.06	6.77 mg/dL Standard Deviation 10.27	9.79 mg/dL Standard Deviation 22.24
C-Reactive Protein (CRP) Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)	4.75 mg/dL Standard Deviation 5.28	7.89 mg/dL Standard Deviation 9.08	16.14 mg/dL Standard Deviation 16.63	12.10 mg/dL Standard Deviation 18.21	8.96 mg/dL Standard Deviation 11.64	8.55 mg/dL Standard Deviation 12.87	7.71 mg/dL Standard Deviation 10.88	11.28 mg/dL Standard Deviation 17.83	7.93 mg/dL Standard Deviation 19.22	5.58 mg/dL Standard Deviation 8.69	3.46 mg/dL Standard Deviation 3.17
C-Reactive Protein (CRP) Week 24 (n=39,20,43,13,53,63,56,52,12,36,17)	4.54 mg/dL Standard Deviation 4.69	7.19 mg/dL Standard Deviation 8.18	13.39 mg/dL Standard Deviation 15.05	16.21 mg/dL Standard Deviation 26.51	7.63 mg/dL Standard Deviation 10.26	6.02 mg/dL Standard Deviation 7.31	10.31 mg/dL Standard Deviation 17.43	12.58 mg/dL Standard Deviation 12.19	5.92 mg/dL Standard Deviation 14.78	6.66 mg/dL Standard Deviation 17.03	6.51 mg/dL Standard Deviation 11.04

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	CP-690,550 20 mg n=74 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=65 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=63 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=63 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=69 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=68 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)	-6.11 mg/dL Standard Deviation 19.97	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.70 mg/dL Standard Deviation 25.55	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.94 mg/dL Standard Deviation 16.03	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.42 mg/dL Standard Deviation 14.21	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.35 mg/dL Standard Deviation 21.25	-4.97 mg/dL Standard Deviation 24.54	-8.67 mg/dL Standard Deviation 18.05
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=61,0,57,0,60,63,62,65,0,60,0)	-5.71 mg/dL Standard Deviation 20.18	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.07 mg/dL Standard Deviation 15.90	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.56 mg/dL Standard Deviation 17.07	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.28 mg/dL Standard Deviation 14.07	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.52 mg/dL Standard Deviation 23.93	-5.96 mg/dL Standard Deviation 23.26	-10.18 mg/dL Standard Deviation 16.26
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)	-8.16 mg/dL Standard Deviation 17.01	-7.59 mg/dL Standard Deviation 12.45	-2.59 mg/dL Standard Deviation 13.79	-13.44 mg/dL Standard Deviation 12.75	-6.96 mg/dL Standard Deviation 10.61	-11.26 mg/dL Standard Deviation 21.64	-7.04 mg/dL Standard Deviation 21.18	-6.33 mg/dL Standard Deviation 10.48	-11.53 mg/dL Standard Deviation 22.00	-8.18 mg/dL Standard Deviation 18.99	-7.01 mg/dL Standard Deviation 27.54
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)	-9.65 mg/dL Standard Deviation 15.32	-10.22 mg/dL Standard Deviation 13.83	0.11 mg/dL Standard Deviation 15.15	-7.52 mg/dL Standard Deviation 20.34	-6.21 mg/dL Standard Deviation 10.94	-9.73 mg/dL Standard Deviation 22.12	-11.31 mg/dL Standard Deviation 16.46	-0.90 mg/dL Standard Deviation 20.08	-7.80 mg/dL Standard Deviation 23.28	-9.60 mg/dL Standard Deviation 19.16	-14.21 mg/dL Standard Deviation 16.73
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=64,0,61,0,66,67,66,69,0,58,0)	-5.03 mg/dL Standard Deviation 17.94	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.51 mg/dL Standard Deviation 12.72	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.92 mg/dL Standard Deviation 16.61	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.97 mg/dL Standard Deviation 17.77	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.81 mg/dL Standard Deviation 23.67	-9.38 mg/dL Standard Deviation 16.02	-10.73 mg/dL Standard Deviation 17.63
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=65,0,63,0,63,69,68,74,0,61,0)	-6.56 mg/dL Standard Deviation 12.70	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.64 mg/dL Standard Deviation 14.26	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.05 mg/dL Standard Deviation 18.32	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.93 mg/dL Standard Deviation 14.85	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.38 mg/dL Standard Deviation 19.27	-9.19 mg/dL Standard Deviation 19.90	-11.87 mg/dL Standard Deviation 15.22
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)	-6.69 mg/dL Standard Deviation 13.99	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.26 mg/dL Standard Deviation 12.51	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.07 mg/dL Standard Deviation 14.44	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.12 mg/dL Standard Deviation 17.24	NA mg/dL Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.54 mg/dL Standard Deviation 16.65	-9.45 mg/dL Standard Deviation 16.27	-11.70 mg/dL Standard Deviation 17.89
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=39,20,43,43,53,63,56,52,12,36,17)	-8.75 mg/dL Standard Deviation 15.40	-10.92 mg/dL Standard Deviation 15.78	-2.16 mg/dL Standard Deviation 16.06	-3.41 mg/dL Standard Deviation 26.61	-7.61 mg/dL Standard Deviation 11.78	-8.07 mg/dL Standard Deviation 10.28	-7.57 mg/dL Standard Deviation 22.26	0.40 mg/dL Standard Deviation 16.50	-8.18 mg/dL Standard Deviation 19.26	-8.72 mg/dL Standard Deviation 22.73	-10.65 mg/dL Standard Deviation 18.76

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

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) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Baseline (n=70,0,68,0,71,74,75,79,0,69,0)	5.34 units on a scale Standard Deviation 0.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.26 units on a scale Standard Deviation 0.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.48 units on a scale Standard Deviation 0.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.31 units on a scale Standard Deviation 0.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.14 units on a scale Standard Deviation 0.84	5.28 units on a scale Standard Deviation 0.85	5.39 units on a scale Standard Deviation 0.89
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 2 (n=64,0,63,0,63,69,68,74,0,61,0)	4.28 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.91 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.88 units on a scale Standard Deviation 1.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.46 units on a scale Standard Deviation 1.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.26 units on a scale Standard Deviation 0.90	4.18 units on a scale Standard Deviation 1.04	4.18 units on a scale Standard Deviation 1.16
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)	3.99 units on a scale Standard Deviation 1.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.60 units on a scale Standard Deviation 1.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.45 units on a scale Standard Deviation 1.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.03 units on a scale Standard Deviation 1.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.03 units on a scale Standard Deviation 0.96	3.66 units on a scale Standard Deviation 1.12	3.75 units on a scale Standard Deviation 1.13
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 6 (n=63,0,61,0,66,67,66,69,0,58,0)	3.94 units on a scale Standard Deviation 1.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.35 units on a scale Standard Deviation 1.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.32 units on a scale Standard Deviation 1.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.74 units on a scale Standard Deviation 1.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.68 units on a scale Standard Deviation 1.00	3.59 units on a scale Standard Deviation 1.27	3.60 units on a scale Standard Deviation 1.13
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)	3.72 units on a scale Standard Deviation 1.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.30 units on a scale Standard Deviation 1.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.21 units on a scale Standard Deviation 1.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.63 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.54 units on a scale Standard Deviation 1.01	3.61 units on a scale Standard Deviation 1.23	3.38 units on a scale Standard Deviation 1.10
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 12 (n=61,0,55,0,60,63,62,65,0,60,0)	3.61 units on a scale Standard Deviation 1.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.37 units on a scale Standard Deviation 1.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.98 units on a scale Standard Deviation 1.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.46 units on a scale Standard Deviation 1.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.57 units on a scale Standard Deviation 1.09	3.40 units on a scale Standard Deviation 1.27	3.28 units on a scale Standard Deviation 1.25
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)	3.14 units on a scale Standard Deviation 1.06	4.65 units on a scale Standard Deviation 1.08	3.93 units on a scale Standard Deviation 1.06	3.91 units on a scale Standard Deviation 1.19	3.59 units on a scale Standard Deviation 1.15	4.33 units on a scale Standard Deviation 1.16	3.11 units on a scale Standard Deviation 1.23	4.19 units on a scale Standard Deviation 1.48	3.19 units on a scale Standard Deviation 1.10	3.34 units on a scale Standard Deviation 1.22	3.12 units on a scale Standard Deviation 1.25
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)	3.08 units on a scale Standard Deviation 1.11	4.82 units on a scale Standard Deviation 1.24	3.81 units on a scale Standard Deviation 1.23	3.86 units on a scale Standard Deviation 1.24	3.48 units on a scale Standard Deviation 1.28	3.83 units on a scale Standard Deviation 1.62	3.06 units on a scale Standard Deviation 1.25	4.24 units on a scale Standard Deviation 1.56	3.09 units on a scale Standard Deviation 1.17	3.14 units on a scale Standard Deviation 1.29	2.94 units on a scale Standard Deviation 1.04
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)	3.07 units on a scale Standard Deviation 0.98	4.51 units on a scale Standard Deviation 1.61	3.48 units on a scale Standard Deviation 1.06	4.08 units on a scale Standard Deviation 1.37	3.39 units on a scale Standard Deviation 1.15	3.88 units on a scale Standard Deviation 1.49	3.14 units on a scale Standard Deviation 1.26	4.08 units on a scale Standard Deviation 1.35	3.03 units on a scale Standard Deviation 1.05	3.15 units on a scale Standard Deviation 1.19	2.91 units on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

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

Measure	CP-690,550 20 mg n=73 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=64 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=63 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=63 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=69 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=68 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=64,0,63,0,63,69,68,73,0,61,0)	-1.01 units on a scale Standard Deviation 0.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.26 units on a scale Standard Deviation 0.78	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.55 units on a scale Standard Deviation 0.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.78 units on a scale Standard Deviation 0.92	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.86 units on a scale Standard Deviation 0.82	-1.07 units on a scale Standard Deviation 0.84	-1.22 units on a scale Standard Deviation 1.08
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=65,0,61,0,62,64,65,69,0,61,0)	-1.30 units on a scale Standard Deviation 1.06	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.57 units on a scale Standard Deviation 0.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.99 units on a scale Standard Deviation 0.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.23 units on a scale Standard Deviation 1.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.09 units on a scale Standard Deviation 0.94	-1.58 units on a scale Standard Deviation 1.09	-1.71 units on a scale Standard Deviation 1.20
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=63,0,61,0,66,67,66,69,0,58,0)	-1.38 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.80 units on a scale Standard Deviation 0.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.13 units on a scale Standard Deviation 1.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.52 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.44 units on a scale Standard Deviation 0.99	-1.66 units on a scale Standard Deviation 1.18	-1.81 units on a scale Standard Deviation 1.17
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)	-1.63 units on a scale Standard Deviation 1.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.83 units on a scale Standard Deviation 1.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.22 units on a scale Standard Deviation 1.14	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.61 units on a scale Standard Deviation 1.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.56 units on a scale Standard Deviation 0.97	-1.63 units on a scale Standard Deviation 1.25	-2.02 units on a scale Standard Deviation 1.14
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=61,0,55,0,60,63,62,65,0,60,0)	-1.72 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.82 units on a scale Standard Deviation 1.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.45 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.85 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.59 units on a scale Standard Deviation 1.18	-1.82 units on a scale Standard Deviation 1.17	-2.13 units on a scale Standard Deviation 1.32
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)	-2.13 units on a scale Standard Deviation 1.04	-0.88 units on a scale Standard Deviation 0.95	-1.14 units on a scale Standard Deviation 1.03	-1.43 units on a scale Standard Deviation 0.70	-1.87 units on a scale Standard Deviation 1.13	-1.14 units on a scale Standard Deviation 0.99	-2.27 units on a scale Standard Deviation 1.14	-0.81 units on a scale Standard Deviation 1.20	-1.93 units on a scale Standard Deviation 1.12	-1.89 units on a scale Standard Deviation 1.13	-2.31 units on a scale Standard Deviation 1.39
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)	-2.17 units on a scale Standard Deviation 0.96	-0.95 units on a scale Standard Deviation 0.81	-1.27 units on a scale Standard Deviation 1.37	-1.47 units on a scale Standard Deviation 1.04	-1.94 units on a scale Standard Deviation 1.26	-1.64 units on a scale Standard Deviation 1.25	-2.41 units on a scale Standard Deviation 1.26	-0.76 units on a scale Standard Deviation 1.22	-2.05 units on a scale Standard Deviation 1.15	-2.09 units on a scale Standard Deviation 1.28	-2.49 units on a scale Standard Deviation 1.26
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)	-2.19 units on a scale Standard Deviation 1.04	-1.26 units on a scale Standard Deviation 1.23	-1.55 units on a scale Standard Deviation 1.25	-1.25 units on a scale Standard Deviation 0.96	-2.06 units on a scale Standard Deviation 1.22	-1.55 units on a scale Standard Deviation 1.07	-2.29 units on a scale Standard Deviation 1.19	-0.92 units on a scale Standard Deviation 1.17	-2.06 units on a scale Standard Deviation 1.04	-2.13 units on a scale Standard Deviation 1.12	-2.49 units on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

Outcome measures

Measure	CP-690,550 20 mg n=74 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=64 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=63 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=63 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=69 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=68 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 4: None (n=65,0,61,0,62,64,65,70,0,61,0)	34.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	57.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.5 percentage of participants	18.8 percentage of participants	20.0 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 6: None (n=63,0,61,0,66,67,66,69,0,58,0)	31.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	25.8 percentage of participants	19.4 percentage of participants	18.2 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 2: Good (n=64,0,63,0,63,69,68,74,0,61,0)	12.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.5 percentage of participants	13.0 percentage of participants	16.2 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 2: Mod (n=64,0,63,0,63,69,68,74,0,61,0)	41.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.9 percentage of participants	46.4 percentage of participants	50.0 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 2: None (n=64,0,63,0,63,69,68,74,0,61,0)	44.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	73.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	71.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.6 percentage of participants	40.6 percentage of participants	33.8 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 4: Good (n=65,0,61,0,62,64,65,70,0,61,0)	21.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.1 percentage of participants	28.1 percentage of participants	30.8 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 4: Mod (n=65,0,61,0,62,64,65,70,0,61,0)	42.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	48.4 percentage of participants	53.1 percentage of participants	49.2 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 6: Good (n=63,0,61,0,66,67,66,69,0,58,0)	23.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.8 percentage of participants	29.9 percentage of participants	31.8 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 6: Mod (n=63,0,61,0,66,67,66,69,0,58,0)	44.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.4 percentage of participants	50.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 8: Good (n=63,0,59,0,62,62,67,67,0,58,0)	37.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.1 percentage of participants	32.3 percentage of participants	43.3 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 8: Mod (n=63,0,59,0,62,62,67,67,0,58,0)	40.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.8 percentage of participants	45.2 percentage of participants	47.8 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 8: None (n=63,0,59,0,62,62,67,67,0,58,0)	22.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.1 percentage of participants	22.6 percentage of participants	9.0 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 12: Good (n=61,0,55,0,60,63,62,65,0,60,0)	36.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.3 percentage of participants	41.3 percentage of participants	51.6 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 12: Mod (n=61,0,55,0,60,63,62,65,0,60,0)	44.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.0 percentage of participants	39.7 percentage of participants	37.1 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 12: None (n=61,0,55,0,60,63,62,65,0,60,0)	18.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.7 percentage of participants	19.0 percentage of participants	11.3 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 16: Good (n=42,21,43,13,54,64,58,55,9,37,16)	52.7 percentage of participants	11.1 percentage of participants	27.0 percentage of participants	18.8 percentage of participants	40.5 percentage of participants	19.0 percentage of participants	55.8 percentage of participants	30.8 percentage of participants	51.9 percentage of participants	50.0 percentage of participants	48.3 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 16: Mod (n=42,21,43,13,54,64,58,55,9,37,16)	43.6 percentage of participants	33.3 percentage of participants	40.5 percentage of participants	62.5 percentage of participants	50.0 percentage of participants	38.1 percentage of participants	32.6 percentage of participants	23.1 percentage of participants	37.0 percentage of participants	34.4 percentage of participants	43.1 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 16: None (n=42,21,43,13,54,64,58,55,9,37,16)	3.6 percentage of participants	55.6 percentage of participants	32.4 percentage of participants	18.8 percentage of participants	9.5 percentage of participants	42.9 percentage of participants	11.6 percentage of participants	46.2 percentage of participants	11.1 percentage of participants	15.6 percentage of participants	8.6 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 20: Good (n=39,21,44,13,57,63,57,55,12,36,17)	52.7 percentage of participants	0.0 percentage of participants	30.6 percentage of participants	29.4 percentage of participants	46.2 percentage of participants	42.9 percentage of participants	59.1 percentage of participants	15.4 percentage of participants	61.4 percentage of participants	52.4 percentage of participants	57.9 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 20: Mod (n=39,21,44,13,57,63,57,55,12,36,17)	40.0 percentage of participants	58.3 percentage of participants	36.1 percentage of participants	47.1 percentage of participants	43.6 percentage of participants	28.6 percentage of participants	31.8 percentage of participants	46.2 percentage of participants	28.1 percentage of participants	36.5 percentage of participants	35.1 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 20: None (n=39,21,44,13,57,63,57,55,12,36,17)	7.3 percentage of participants	41.7 percentage of participants	33.3 percentage of participants	23.5 percentage of participants	10.3 percentage of participants	28.6 percentage of participants	9.1 percentage of participants	38.5 percentage of participants	10.5 percentage of participants	11.1 percentage of participants	7.0 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 24: Good (n=39,20,42,13,53,63,56,52,12,36,17)	59.6 percentage of participants	25.0 percentage of participants	33.3 percentage of participants	23.5 percentage of participants	43.6 percentage of participants	35.0 percentage of participants	54.8 percentage of participants	23.1 percentage of participants	52.8 percentage of participants	58.7 percentage of participants	66.1 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 24: Mod (n=39,20,42,13,53,63,56,52,12,36,17)	34.6 percentage of participants	33.3 percentage of participants	41.7 percentage of participants	47.1 percentage of participants	46.2 percentage of participants	35.0 percentage of participants	33.3 percentage of participants	38.5 percentage of participants	37.7 percentage of participants	30.2 percentage of participants	23.2 percentage of participants
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) Week 24: None (n=39,20,42,13,53,63,56,52,12,36,17)	5.8 percentage of participants	41.7 percentage of participants	25.0 percentage of participants	29.4 percentage of participants	10.3 percentage of participants	30.0 percentage of participants	11.9 percentage of participants	38.5 percentage of participants	9.4 percentage of participants	11.1 percentage of participants	10.7 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

DAS28-3 (CRP) defined remission was classified as a score of <2.6.

Outcome measures

Measure	CP-690,550 20 mg n=74 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=64 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=63 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=63 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=68 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=68 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 2 (n=64,0,63,0,63,68,68,74,0,61,0)	4.05 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.28 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.56 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.17 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.59 percentage of participants	4.41 percentage of participants	13.24 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 4 (n=65,0,61,0,62,63,65,70,0,61,0)	10.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.28 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.62 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.75 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.06 percentage of participants	19.05 percentage of participants	16.92 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 6 (n=63,0,61,0,66,66,66,69,0,58,0)	10.14 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.45 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.17 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.64 percentage of participants	24.24 percentage of participants	22.73 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 8 (n=63,0,59,0,62,61,67,67,0,58,0)	20.90 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.90 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.94 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.03 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.35 percentage of participants	21.31 percentage of participants	23.88 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 12 (n=61,0,55,0,60,62,62,65,0,60,0)	24.62 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.56 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.91 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.67 percentage of participants	32.26 percentage of participants	37.10 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 16 (n=42,21,43,13,54,63,58,55,9,37,16)	29.1 percentage of participants	11.1 percentage of participants	8.1 percentage of participants	12.5 percentage of participants	14.3 percentage of participants	9.5 percentage of participants	41.9 percentage of participants	23.1 percentage of participants	24.1 percentage of participants	30.2 percentage of participants	37.9 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 20 (n=39,21,44,13,57,62,57,55,12,36,17)	30.9 percentage of participants	0.0 percentage of participants	13.9 percentage of participants	17.6 percentage of participants	20.5 percentage of participants	28.6 percentage of participants	43.2 percentage of participants	15.4 percentage of participants	35.1 percentage of participants	37.1 percentage of participants	38.6 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)	32.7 percentage of participants	16.7 percentage of participants	19.4 percentage of participants	17.6 percentage of participants	23.1 percentage of participants	25.0 percentage of participants	35.7 percentage of participants	15.4 percentage of participants	41.5 percentage of participants	36.5 percentage of participants	39.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=20 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
36-Item Short-Form Health Survey (SF-36) Week 24: So Fn(n=40,20,44,13,55,64,60,53,12,36,17)	46.35 units on a scale Standard Deviation 10.53	38.67 units on a scale Standard Deviation 12.38	45.18 units on a scale Standard Deviation 10.60	43.05 units on a scale Standard Deviation 10.04	43.62 units on a scale Standard Deviation 10.40	39.40 units on a scale Standard Deviation 10.26	42.84 units on a scale Standard Deviation 12.53	43.84 units on a scale Standard Deviation 9.05	45.25 units on a scale Standard Deviation 11.64	43.56 units on a scale Standard Deviation 10.73	44.67 units on a scale Standard Deviation 10.31
36-Item Short-Form Health Survey (SF-36) Week 24: R-E (n=40,20,44,13,55,64,60,53,12,36,17)	42.31 units on a scale Standard Deviation 13.71	37.09 units on a scale Standard Deviation 16.56	42.27 units on a scale Standard Deviation 13.09	46.28 units on a scale Standard Deviation 9.13	40.23 units on a scale Standard Deviation 11.08	34.30 units on a scale Standard Deviation 10.59	40.59 units on a scale Standard Deviation 13.86	37.94 units on a scale Standard Deviation 12.35	41.46 units on a scale Standard Deviation 12.40	40.15 units on a scale Standard Deviation 11.58	40.39 units on a scale Standard Deviation 11.88
36-Item Short-Form Health Survey (SF-36) Week 12: Ph Fn (n=63,0,59,0,64,65,65,70,0,61,0)	37.49 units on a scale Standard Deviation 11.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.23 units on a scale Standard Deviation 11.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.05 units on a scale Standard Deviation 10.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.49 units on a scale Standard Deviation 11.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.45 units on a scale Standard Deviation 9.78	36.25 units on a scale Standard Deviation 10.75	37.80 units on a scale Standard Deviation 10.76
36-Item Short-Form Health Survey (SF-36) Week 12: R-P (n=63,0,59,0,64,65,65,70,0,61,0)	40.17 units on a scale Standard Deviation 10.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.79 units on a scale Standard Deviation 10.14	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.47 units on a scale Standard Deviation 8.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.25 units on a scale Standard Deviation 10.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.26 units on a scale Standard Deviation 10.21	39.71 units on a scale Standard Deviation 9.69	39.41 units on a scale Standard Deviation 10.03
36-Item Short-Form Health Survey (SF-36) Week 12: BP (n=63,0,59,0,64,65,65,70,0,61,0)	44.21 units on a scale Standard Deviation 9.78	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.46 units on a scale Standard Deviation 10.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.62 units on a scale Standard Deviation 8.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.76 units on a scale Standard Deviation 11.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.73 units on a scale Standard Deviation 9.57	44.00 units on a scale Standard Deviation 10.81	44.39 units on a scale Standard Deviation 9.40
36-Item Short-Form Health Survey (SF-36) Week 12: Vit (n=63,0,59,0,64,65,65,70,0,61,0)	46.03 units on a scale Standard Deviation 11.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.48 units on a scale Standard Deviation 12.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.45 units on a scale Standard Deviation 9.82	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.80 units on a scale Standard Deviation 10.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.33 units on a scale Standard Deviation 10.59	45.99 units on a scale Standard Deviation 10.68	47.82 units on a scale Standard Deviation 10.24
36-Item Short-Form Health Survey (SF-36) Week 12: So Fn (n=63,0,59,0,64,65,65,70,0,61,0)	44.23 units on a scale Standard Deviation 10.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.38 units on a scale Standard Deviation 10.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.18 units on a scale Standard Deviation 11.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.54 units on a scale Standard Deviation 11.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.28 units on a scale Standard Deviation 10.82	42.84 units on a scale Standard Deviation 10.06	43.93 units on a scale Standard Deviation 9.81
36-Item Short-Form Health Survey (SF-36) Week 12: R-E (n=63,0,59,0,64,65,65,70,0,61,0)	41.33 units on a scale Standard Deviation 13.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.39 units on a scale Standard Deviation 12.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.47 units on a scale Standard Deviation 12.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.14 units on a scale Standard Deviation 12.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.90 units on a scale Standard Deviation 12.87	39.01 units on a scale Standard Deviation 12.07	39.07 units on a scale Standard Deviation 11.96
36-Item Short-Form Health Survey (SF-36) Week 24: GH (n=40,20,44,13,55,64,60,53,12,36,17)	44.03 units on a scale Standard Deviation 9.52	35.81 units on a scale Standard Deviation 11.52	43.16 units on a scale Standard Deviation 9.70	40.68 units on a scale Standard Deviation 8.34	40.65 units on a scale Standard Deviation 7.40	36.87 units on a scale Standard Deviation 7.75	41.45 units on a scale Standard Deviation 10.05	37.35 units on a scale Standard Deviation 5.95	41.35 units on a scale Standard Deviation 10.23	41.09 units on a scale Standard Deviation 9.27	41.40 units on a scale Standard Deviation 9.24
36-Item Short-Form Health Survey (SF-36) Week 24: MnH (n=40,20,44,13,55,64,60,53,12,36,17)	47.24 units on a scale Standard Deviation 11.36	43.44 units on a scale Standard Deviation 12.84	45.63 units on a scale Standard Deviation 14.22	47.52 units on a scale Standard Deviation 11.26	45.92 units on a scale Standard Deviation 11.10	38.74 units on a scale Standard Deviation 10.58	45.66 units on a scale Standard Deviation 12.59	44.59 units on a scale Standard Deviation 7.04	47.29 units on a scale Standard Deviation 13.62	43.89 units on a scale Standard Deviation 10.93	46.86 units on a scale Standard Deviation 11.73
36-Item Short-Form Health Survey (SF-36) Week 24: Ph C (n=40,20,44,13,55,64,60,53,12,36,17)	42.81 units on a scale Standard Deviation 10.22	34.40 units on a scale Standard Deviation 10.57	42.09 units on a scale Standard Deviation 9.20	39.41 units on a scale Standard Deviation 9.58	39.94 units on a scale Standard Deviation 8.41	36.79 units on a scale Standard Deviation 9.76	40.31 units on a scale Standard Deviation 9.95	39.74 units on a scale Standard Deviation 9.76	41.12 units on a scale Standard Deviation 9.22	40.85 units on a scale Standard Deviation 9.79	40.99 units on a scale Standard Deviation 9.14
36-Item Short-Form Health Survey (SF-36) Week 24: Mn C(n=40,20,44,13,55,64,60,53,12,36,17)	48.03 units on a scale Standard Deviation 11.81	43.35 units on a scale Standard Deviation 13.89	47.08 units on a scale Standard Deviation 15.31	49.27 units on a scale Standard Deviation 9.52	46.62 units on a scale Standard Deviation 12.04	39.10 units on a scale Standard Deviation 11.18	46.21 units on a scale Standard Deviation 13.26	44.52 units on a scale Standard Deviation 7.18	47.34 units on a scale Standard Deviation 13.41	45.03 units on a scale Standard Deviation 11.20	47.21 units on a scale Standard Deviation 11.71
36-Item Short-Form Health Survey (SF-36) Baseline: R-E (n=70,0,68,0,71,73,75,80,0,69,0)	35.13 units on a scale Standard Deviation 13.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.37 units on a scale Standard Deviation 13.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.72 units on a scale Standard Deviation 11.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.18 units on a scale Standard Deviation 14.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.21 units on a scale Standard Deviation 12.51	36.23 units on a scale Standard Deviation 12.64	34.73 units on a scale Standard Deviation 14.42
36-Item Short-Form Health Survey (SF-36) Baseline: Ph Fn (n=70,0,68,0,71,73,75,80,0,69,0)	30.23 units on a scale Standard Deviation 9.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.01 units on a scale Standard Deviation 11.06	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.48 units on a scale Standard Deviation 10.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.20 units on a scale Standard Deviation 11.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.93 units on a scale Standard Deviation 9.66	31.92 units on a scale Standard Deviation 9.15	31.50 units on a scale Standard Deviation 9.29
36-Item Short-Form Health Survey (SF-36) Baseline: R-P (n=70,0,68,0,71,73,75,80,0,69,0)	33.13 units on a scale Standard Deviation 9.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.23 units on a scale Standard Deviation 9.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.53 units on a scale Standard Deviation 8.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.45 units on a scale Standard Deviation 10.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.54 units on a scale Standard Deviation 8.69	34.64 units on a scale Standard Deviation 10.72	33.70 units on a scale Standard Deviation 9.85
36-Item Short-Form Health Survey (SF-36) Baseline: BP (n=70,0,68,0,71,73,75,80,0,69,0)	34.20 units on a scale Standard Deviation 8.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.93 units on a scale Standard Deviation 8.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.14 units on a scale Standard Deviation 6.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.60 units on a scale Standard Deviation 8.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.36 units on a scale Standard Deviation 8.23	35.11 units on a scale Standard Deviation 7.85	34.98 units on a scale Standard Deviation 8.19
36-Item Short-Form Health Survey (SF-36) Baseline: GH (n=70,0,68,0,71,73,75,80,0,69,0)	36.08 units on a scale Standard Deviation 8.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.50 units on a scale Standard Deviation 9.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.08 units on a scale Standard Deviation 6.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.17 units on a scale Standard Deviation 8.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.12 units on a scale Standard Deviation 8.90	36.52 units on a scale Standard Deviation 9.28	35.94 units on a scale Standard Deviation 8.44
36-Item Short-Form Health Survey (SF-36) Baseline: Vit (n=70,0,68,0,71,73,75,80,0,69,0)	40.97 units on a scale Standard Deviation 9.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.08 units on a scale Standard Deviation 11.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.32 units on a scale Standard Deviation 9.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.36 units on a scale Standard Deviation 10.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.54 units on a scale Standard Deviation 9.39	42.60 units on a scale Standard Deviation 10.83	40.81 units on a scale Standard Deviation 11.75
36-Item Short-Form Health Survey (SF-36) Baseline: So Fn (n=70,0,68,0,71,73,75,80,0,69,0)	38.03 units on a scale Standard Deviation 10.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.09 units on a scale Standard Deviation 11.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.76 units on a scale Standard Deviation 10.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.88 units on a scale Standard Deviation 11.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.72 units on a scale Standard Deviation 10.38	38.99 units on a scale Standard Deviation 10.80	38.01 units on a scale Standard Deviation 11.06
36-Item Short-Form Health Survey (SF-36) Baseline: MnH (n=70,0,68,0,71,73,75,80,0,69,0)	39.91 units on a scale Standard Deviation 12.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.91 units on a scale Standard Deviation 13.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.98 units on a scale Standard Deviation 11.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.07 units on a scale Standard Deviation 11.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.88 units on a scale Standard Deviation 12.02	42.79 units on a scale Standard Deviation 10.99	39.68 units on a scale Standard Deviation 12.65
36-Item Short-Form Health Survey (SF-36) Baseline: Ph C (n=70,0,68,0,71,73,75,80,0,69,0)	32.11 units on a scale Standard Deviation 8.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.41 units on a scale Standard Deviation 8.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.13 units on a scale Standard Deviation 6.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.73 units on a scale Standard Deviation 8.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.99 units on a scale Standard Deviation 8.03	32.96 units on a scale Standard Deviation 8.15	33.19 units on a scale Standard Deviation 7.31
36-Item Short-Form Health Survey (SF-36) Baseline: Mn C (n=70,0,68,0,71,73,75,80,0,69,0)	41.68 units on a scale Standard Deviation 12.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.72 units on a scale Standard Deviation 13.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.39 units on a scale Standard Deviation 11.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.47 units on a scale Standard Deviation 12.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.81 units on a scale Standard Deviation 11.80	43.53 units on a scale Standard Deviation 11.00	40.92 units on a scale Standard Deviation 13.00
36-Item Short-Form Health Survey (SF-36) Week 12: GH (n=63,0,59,0,64,65,65,70,0,61,0)	41.10 units on a scale Standard Deviation 9.78	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.54 units on a scale Standard Deviation 10.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.85 units on a scale Standard Deviation 8.10	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.04 units on a scale Standard Deviation 8.74	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.11 units on a scale Standard Deviation 9.54	39.15 units on a scale Standard Deviation 8.76	40.05 units on a scale Standard Deviation 9.44
36-Item Short-Form Health Survey (SF-36) Week 12: MnH (n=63,0,59,0,64,65,65,70,0,61,0)	46.11 units on a scale Standard Deviation 11.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.36 units on a scale Standard Deviation 12.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.84 units on a scale Standard Deviation 10.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.57 units on a scale Standard Deviation 10.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.34 units on a scale Standard Deviation 13.08	43.08 units on a scale Standard Deviation 9.84	45.24 units on a scale Standard Deviation 10.70
36-Item Short-Form Health Survey (SF-36) Week 12: Ph C (n=63,0,59,0,64,65,65,70,0,61,0)	39.64 units on a scale Standard Deviation 10.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.89 units on a scale Standard Deviation 9.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.24 units on a scale Standard Deviation 8.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.70 units on a scale Standard Deviation 9.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.27 units on a scale Standard Deviation 9.31	39.52 units on a scale Standard Deviation 9.30	39.97 units on a scale Standard Deviation 8.98
36-Item Short-Form Health Survey (SF-36) Week 12: Mn C (n=63,0,59,0,64,65,65,70,0,61,0)	46.65 units on a scale Standard Deviation 11.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.08 units on a scale Standard Deviation 12.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.86 units on a scale Standard Deviation 11.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.47 units on a scale Standard Deviation 11.10	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.84 units on a scale Standard Deviation 13.41	44.18 units on a scale Standard Deviation 10.26	45.61 units on a scale Standard Deviation 10.59
36-Item Short-Form Health Survey (SF-36) Week 24: Ph Fn(n=40,20,44,13,55,64,60,53,12,36,17)	40.51 units on a scale Standard Deviation 12.11	32.31 units on a scale Standard Deviation 11.36	39.44 units on a scale Standard Deviation 10.64	38.09 units on a scale Standard Deviation 10.04	37.41 units on a scale Standard Deviation 10.35	34.30 units on a scale Standard Deviation 10.72	38.38 units on a scale Standard Deviation 11.35	39.39 units on a scale Standard Deviation 11.83	40.04 units on a scale Standard Deviation 10.81	38.19 units on a scale Standard Deviation 10.88	38.62 units on a scale Standard Deviation 11.08
36-Item Short-Form Health Survey (SF-36) Week 24: R-P (n=40,20,44,13,55,64,60,53,12,36,17)	41.97 units on a scale Standard Deviation 10.80	35.02 units on a scale Standard Deviation 10.72	44.27 units on a scale Standard Deviation 9.80	42.45 units on a scale Standard Deviation 9.44	40.51 units on a scale Standard Deviation 8.53	35.06 units on a scale Standard Deviation 9.36	39.88 units on a scale Standard Deviation 11.85	38.96 units on a scale Standard Deviation 10.26	41.09 units on a scale Standard Deviation 9.12	40.32 units on a scale Standard Deviation 10.91	40.69 units on a scale Standard Deviation 9.67
36-Item Short-Form Health Survey (SF-36) Week 24: BP (n=40,20,44,13,55,64,60,53,12,36,17)	46.89 units on a scale Standard Deviation 10.25	40.32 units on a scale Standard Deviation 11.00	43.11 units on a scale Standard Deviation 9.54	44.24 units on a scale Standard Deviation 8.09	44.17 units on a scale Standard Deviation 8.68	39.57 units on a scale Standard Deviation 11.54	44.15 units on a scale Standard Deviation 10.31	43.07 units on a scale Standard Deviation 9.91	44.96 units on a scale Standard Deviation 9.23	44.52 units on a scale Standard Deviation 10.98	45.76 units on a scale Standard Deviation 9.67
36-Item Short-Form Health Survey (SF-36) Week 24: Vit (n=40,20,44,13,55,64,60,53,12,36,17)	50.50 units on a scale Standard Deviation 10.98	41.94 units on a scale Standard Deviation 13.65	49.75 units on a scale Standard Deviation 11.83	48.23 units on a scale Standard Deviation 11.92	49.05 units on a scale Standard Deviation 10.69	39.60 units on a scale Standard Deviation 9.23	48.76 units on a scale Standard Deviation 11.25	47.29 units on a scale Standard Deviation 6.58	48.40 units on a scale Standard Deviation 10.41	47.55 units on a scale Standard Deviation 10.18	50.11 units on a scale Standard Deviation 11.68

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Measure	CP-690,550 20 mg n=70 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=63 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=20 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=59 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=64 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=64 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=65 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Ph Fn (n=63,0,59,0,64,64,65,70,0,61,0)	7.40 units on a scale Standard Deviation 9.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.24 units on a scale Standard Deviation 8.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.98 units on a scale Standard Deviation 7.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.39 units on a scale Standard Deviation 9.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.57 units on a scale Standard Deviation 8.25	4.18 units on a scale Standard Deviation 11.13	5.96 units on a scale Standard Deviation 8.21
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: R-P (n=63,0,59,0,64,64,65,70,0,61,0)	6.86 units on a scale Standard Deviation 9.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.01 units on a scale Standard Deviation 9.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.77 units on a scale Standard Deviation 8.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.61 units on a scale Standard Deviation 11.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.68 units on a scale Standard Deviation 9.44	4.52 units on a scale Standard Deviation 11.62	5.20 units on a scale Standard Deviation 9.27
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: BP (n=63,0,59,0,64,64,65,70,0,61,0)	10.54 units on a scale Standard Deviation 9.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.23 units on a scale Standard Deviation 8.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.29 units on a scale Standard Deviation 8.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.80 units on a scale Standard Deviation 11.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.28 units on a scale Standard Deviation 10.29	8.74 units on a scale Standard Deviation 10.66	9.23 units on a scale Standard Deviation 9.48
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: GH (n=63,0,59,0,64,64,65,70,0,61,0)	4.97 units on a scale Standard Deviation 9.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.47 units on a scale Standard Deviation 10.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.94 units on a scale Standard Deviation 7.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.84 units on a scale Standard Deviation 7.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.78 units on a scale Standard Deviation 8.81	2.73 units on a scale Standard Deviation 7.46	4.32 units on a scale Standard Deviation 8.59
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Vit (n=63,0,59,0,64,64,65,70,0,61,0)	5.22 units on a scale Standard Deviation 8.28	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.45 units on a scale Standard Deviation 11.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.10 units on a scale Standard Deviation 8.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.29 units on a scale Standard Deviation 9.92	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.68 units on a scale Standard Deviation 9.86	2.29 units on a scale Standard Deviation 8.80	6.87 units on a scale Standard Deviation 8.76
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: MnH (n=63,0,59,0,64,64,65,70,0,61,0)	5.59 units on a scale Standard Deviation 9.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.88 units on a scale Standard Deviation 9.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.92 units on a scale Standard Deviation 9.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.63 units on a scale Standard Deviation 10.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.43 units on a scale Standard Deviation 10.19	0.04 units on a scale Standard Deviation 9.08	4.68 units on a scale Standard Deviation 8.73
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Mn C (n=63,0,59,0,64,64,65,70,0,61,0)	4.18 units on a scale Standard Deviation 10.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.40 units on a scale Standard Deviation 9.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.30 units on a scale Standard Deviation 9.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.94 units on a scale Standard Deviation 10.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.72 units on a scale Standard Deviation 9.57	0.28 units on a scale Standard Deviation 10.13	3.81 units on a scale Standard Deviation 9.58
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Ph Fn(n=40,20,44,13,55,63,60,53,12,36,17)	8.81 units on a scale Standard Deviation 10.48	6.49 units on a scale Standard Deviation 8.15	3.74 units on a scale Standard Deviation 9.56	4.21 units on a scale Standard Deviation 9.84	6.52 units on a scale Standard Deviation 8.32	2.63 units on a scale Standard Deviation 9.94	5.45 units on a scale Standard Deviation 8.57	4.37 units on a scale Standard Deviation 8.35	7.77 units on a scale Standard Deviation 9.41	6.41 units on a scale Standard Deviation 11.62	6.63 units on a scale Standard Deviation 10.30
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: BP (n=40,20,44,13,55,63,60,53,12,36,17)	11.86 units on a scale Standard Deviation 10.67	10.67 units on a scale Standard Deviation 12.01	5.92 units on a scale Standard Deviation 10.51	7.73 units on a scale Standard Deviation 7.63	10.65 units on a scale Standard Deviation 9.91	3.85 units on a scale Standard Deviation 8.92	10.16 units on a scale Standard Deviation 9.54	9.75 units on a scale Standard Deviation 7.27	10.09 units on a scale Standard Deviation 10.44	9.21 units on a scale Standard Deviation 10.31	10.44 units on a scale Standard Deviation 10.51
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: GH (n=40,20,44,13,55,63,60,53,12,36,17)	6.43 units on a scale Standard Deviation 8.93	5.92 units on a scale Standard Deviation 9.84	4.20 units on a scale Standard Deviation 12.05	4.04 units on a scale Standard Deviation 3.82	5.62 units on a scale Standard Deviation 7.70	3.58 units on a scale Standard Deviation 6.97	5.92 units on a scale Standard Deviation 7.09	4.11 units on a scale Standard Deviation 9.07	6.34 units on a scale Standard Deviation 7.85	4.68 units on a scale Standard Deviation 8.77	5.41 units on a scale Standard Deviation 7.88
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: So Fn(n=40,20,44,13,55,63,60,53,12,36,17)	6.79 units on a scale Standard Deviation 11.86	3.64 units on a scale Standard Deviation 11.71	3.33 units on a scale Standard Deviation 12.73	3.85 units on a scale Standard Deviation 9.20	5.86 units on a scale Standard Deviation 9.36	3.27 units on a scale Standard Deviation 12.31	4.09 units on a scale Standard Deviation 11.10	5.87 units on a scale Standard Deviation 10.31	7.54 units on a scale Standard Deviation 10.36	4.16 units on a scale Standard Deviation 11.99	4.91 units on a scale Standard Deviation 10.27
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: R-E (n=40,20,44,13,55,63,60,53,12,36,17)	5.57 units on a scale Standard Deviation 14.61	2.27 units on a scale Standard Deviation 16.86	0.97 units on a scale Standard Deviation 13.70	2.29 units on a scale Standard Deviation 11.17	4.28 units on a scale Standard Deviation 11.30	2.33 units on a scale Standard Deviation 12.82	5.48 units on a scale Standard Deviation 16.05	-0.30 units on a scale Standard Deviation 13.69	4.24 units on a scale Standard Deviation 11.81	4.01 units on a scale Standard Deviation 13.30	5.18 units on a scale Standard Deviation 11.73
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Mn C (n=40,20,44,13,55,63,60,53,12,36,17)	4.52 units on a scale Standard Deviation 12.52	3.44 units on a scale Standard Deviation 14.10	-0.07 units on a scale Standard Deviation 12.42	1.57 units on a scale Standard Deviation 8.22	5.48 units on a scale Standard Deviation 12.35	1.93 units on a scale Standard Deviation 11.99	4.31 units on a scale Standard Deviation 13.10	2.48 units on a scale Standard Deviation 11.80	4.46 units on a scale Standard Deviation 10.55	0.73 units on a scale Standard Deviation 10.85	4.78 units on a scale Standard Deviation 9.04
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: So Fn (n=63,0,59,0,64,64,65,70,0,61,0)	5.84 units on a scale Standard Deviation 12.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.80 units on a scale Standard Deviation 9.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.72 units on a scale Standard Deviation 10.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.99 units on a scale Standard Deviation 10.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.26 units on a scale Standard Deviation 9.93	3.49 units on a scale Standard Deviation 11.84	4.70 units on a scale Standard Deviation 10.33
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: R-E (n=63,0,59,0,64,64,65,70,0,61,0)	5.33 units on a scale Standard Deviation 12.06	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.96 units on a scale Standard Deviation 12.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.26 units on a scale Standard Deviation 10.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.69 units on a scale Standard Deviation 13.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.25 units on a scale Standard Deviation 11.23	2.73 units on a scale Standard Deviation 13.28	3.77 units on a scale Standard Deviation 13.04
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Ph C (n=63,0,59,0,64,64,65,70,0,61,0)	7.98 units on a scale Standard Deviation 7.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.71 units on a scale Standard Deviation 7.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.27 units on a scale Standard Deviation 6.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.16 units on a scale Standard Deviation 8.82	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.30 units on a scale Standard Deviation 8.03	6.32 units on a scale Standard Deviation 8.72	6.77 units on a scale Standard Deviation 7.29
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: R-P (n=40,20,44,13,55,63,60,53,12,36,17)	7.25 units on a scale Standard Deviation 11.27	5.51 units on a scale Standard Deviation 10.50	5.85 units on a scale Standard Deviation 11.43	4.75 units on a scale Standard Deviation 8.64	6.12 units on a scale Standard Deviation 8.34	1.47 units on a scale Standard Deviation 7.72	5.07 units on a scale Standard Deviation 11.00	4.52 units on a scale Standard Deviation 6.77	6.01 units on a scale Standard Deviation 10.23	5.56 units on a scale Standard Deviation 9.76	6.61 units on a scale Standard Deviation 9.33
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Vit (n=40,20,44,13,55,63,60,53,12,36,17)	7.95 units on a scale Standard Deviation 11.17	6.76 units on a scale Standard Deviation 11.52	2.08 units on a scale Standard Deviation 13.86	6.06 units on a scale Standard Deviation 6.19	8.12 units on a scale Standard Deviation 9.94	1.56 units on a scale Standard Deviation 10.79	5.82 units on a scale Standard Deviation 9.30	5.04 units on a scale Standard Deviation 10.16	6.64 units on a scale Standard Deviation 9.03	3.52 units on a scale Standard Deviation 9.27	8.53 units on a scale Standard Deviation 9.99
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: MnH (n=40,20,44,13,55,63,60,53,12,36,17)	5.31 units on a scale Standard Deviation 12.73	6.57 units on a scale Standard Deviation 12.84	0.70 units on a scale Standard Deviation 9.97	0.99 units on a scale Standard Deviation 10.10	7.25 units on a scale Standard Deviation 12.82	1.83 units on a scale Standard Deviation 8.73	4.99 units on a scale Standard Deviation 11.52	4.98 units on a scale Standard Deviation 11.27	5.43 units on a scale Standard Deviation 11.92	0.36 units on a scale Standard Deviation 10.48	5.44 units on a scale Standard Deviation 8.23
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Ph C (n=40,20,44,13,55,63,60,53,12,36,17)	9.59 units on a scale Standard Deviation 8.67	7.83 units on a scale Standard Deviation 7.89	6.26 units on a scale Standard Deviation 9.97	6.40 units on a scale Standard Deviation 8.08	7.47 units on a scale Standard Deviation 7.90	2.91 units on a scale Standard Deviation 7.31	6.78 units on a scale Standard Deviation 7.17	6.62 units on a scale Standard Deviation 5.93	8.31 units on a scale Standard Deviation 8.48	7.99 units on a scale Standard Deviation 9.21	7.81 units on a scale Standard Deviation 8.84

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score Week 12 (n=63,0,59,0,64,65,64,70,0,61,0)	0.64 units on a scale Standard Deviation 0.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.55 units on a scale Standard Deviation 0.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.63 units on a scale Standard Deviation 0.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.59 units on a scale Standard Deviation 0.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.62 units on a scale Standard Deviation 0.26	0.65 units on a scale Standard Deviation 0.23	0.63 units on a scale Standard Deviation 0.27
Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score Week 24 (n=40,20,44,13,55,63,60,52,12,36,17)	0.71 units on a scale Standard Deviation 0.27	0.56 units on a scale Standard Deviation 0.32	0.65 units on a scale Standard Deviation 0.22	0.58 units on a scale Standard Deviation 0.32	0.66 units on a scale Standard Deviation 0.23	0.46 units on a scale Standard Deviation 0.42	0.67 units on a scale Standard Deviation 0.26	0.64 units on a scale Standard Deviation 0.25	0.70 units on a scale Standard Deviation 0.23	0.68 units on a scale Standard Deviation 0.23	0.65 units on a scale Standard Deviation 0.25
Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score Baseline (n=70,0,68,0,71,74,75,80,0,69,0)	0.49 units on a scale Standard Deviation 0.28	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.49 units on a scale Standard Deviation 0.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.45 units on a scale Standard Deviation 0.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.46 units on a scale Standard Deviation 0.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.50 units on a scale Standard Deviation 0.30	0.48 units on a scale Standard Deviation 0.28	0.46 units on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	CP-690,550 20 mg n=70 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=61 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=63 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=20 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=59 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=64 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=65 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=64 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET Week 12 (n=63,0,59,0,64,65,64,70,0,61,0)	0.16 units on a scale Standard Deviation 0.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.05 units on a scale Standard Deviation 0.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.15 units on a scale Standard Deviation 0.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.16 units on a scale Standard Deviation 0.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.11 units on a scale Standard Deviation 0.32	0.17 units on a scale Standard Deviation 0.27	0.18 units on a scale Standard Deviation 0.29
Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET Week 24 (n=40,20,44,13,55,63,60,52,12,36,17)	0.17 units on a scale Standard Deviation 0.32	0.20 units on a scale Standard Deviation 0.45	0.13 units on a scale Standard Deviation 0.30	0.03 units on a scale Standard Deviation 0.29	0.20 units on a scale Standard Deviation 0.30	0.00 units on a scale Standard Deviation 0.30	0.23 units on a scale Standard Deviation 0.33	0.23 units on a scale Standard Deviation 0.37	0.19 units on a scale Standard Deviation 0.30	0.20 units on a scale Standard Deviation 0.31	0.18 units on a scale Standard Deviation 0.29

SECONDARY outcome

Timeframe: Baseline, Week 2, 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

Outcome measures

Measure	CP-690,550 20 mg n=80 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=74 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SPS (n=70,0,68,0,71,74,74,80,0,69,0)	38.46 units on a scale Standard Deviation 21.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.26 units on a scale Standard Deviation 19.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.62 units on a scale Standard Deviation 18.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.46 units on a scale Standard Deviation 21.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.12 units on a scale Standard Deviation 18.93	36.94 units on a scale Standard Deviation 18.49	40.90 units on a scale Standard Deviation 22.41
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: OSP (n=70,0,68,0,71,74,74,79,0,69,0)	40.49 units on a scale Standard Deviation 21.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.86 units on a scale Standard Deviation 19.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.94 units on a scale Standard Deviation 18.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.65 units on a scale Standard Deviation 20.86	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.22 units on a scale Standard Deviation 19.00	39.05 units on a scale Standard Deviation 18.56	42.87 units on a scale Standard Deviation 20.62
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Ade (n=70,0,68,0,71,74,74,80,0,69,0)	51.00 units on a scale Standard Deviation 30.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.45 units on a scale Standard Deviation 28.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	48.14 units on a scale Standard Deviation 25.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.82 units on a scale Standard Deviation 26.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.20 units on a scale Standard Deviation 27.95	50.27 units on a scale Standard Deviation 26.84	49.19 units on a scale Standard Deviation 28.13
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: ASOB (n=70,0,68,0,71,74,75,80,0,69,0)	20.50 units on a scale Standard Deviation 27.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.61 units on a scale Standard Deviation 25.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.00 units on a scale Standard Deviation 24.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.94 units on a scale Standard Deviation 24.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.75 units on a scale Standard Deviation 22.82	17.30 units on a scale Standard Deviation 22.29	21.87 units on a scale Standard Deviation 25.93
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SD (n=70,0,68,0,71,74,75,80,0,69,0)	44.42 units on a scale Standard Deviation 27.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.34 units on a scale Standard Deviation 26.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.43 units on a scale Standard Deviation 23.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.10 units on a scale Standard Deviation 27.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.61 units on a scale Standard Deviation 25.40	41.17 units on a scale Standard Deviation 25.36	48.37 units on a scale Standard Deviation 25.66
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Opt (n=70,0,68,0,71,74,75,80,0,69,0)	0.50 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.52 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.51 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.44 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.46 units on a scale Standard Deviation 0.50	0.45 units on a scale Standard Deviation 0.50	0.47 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Qua (n=70,0,67,0,71,74,75,78,0,69,0)	6.90 units on a scale Standard Deviation 1.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.71 units on a scale Standard Deviation 1.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.87 units on a scale Standard Deviation 1.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.72 units on a scale Standard Deviation 1.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.32 units on a scale Standard Deviation 7.65	7.28 units on a scale Standard Deviation 3.54	6.64 units on a scale Standard Deviation 1.61
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Sno (n=69,0,68,0,71,74,74,80,0,69,0)	35.25 units on a scale Standard Deviation 32.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.94 units on a scale Standard Deviation 33.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.59 units on a scale Standard Deviation 30.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.29 units on a scale Standard Deviation 32.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.51 units on a scale Standard Deviation 33.16	39.73 units on a scale Standard Deviation 33.19	36.00 units on a scale Standard Deviation 34.01
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SPS (n=67,0,68,0,68,73,73,79,0,65,0)	35.78 units on a scale Standard Deviation 20.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.34 units on a scale Standard Deviation 20.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.65 units on a scale Standard Deviation 21.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.89 units on a scale Standard Deviation 22.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.22 units on a scale Standard Deviation 21.10	35.25 units on a scale Standard Deviation 19.10	32.97 units on a scale Standard Deviation 21.75
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Ade (n=40,20,44,13,55,64,59,52,12,34,17)	66.92 units on a scale Standard Deviation 28.60	44.17 units on a scale Standard Deviation 34.50	57.65 units on a scale Standard Deviation 27.64	55.29 units on a scale Standard Deviation 33.56	57.00 units on a scale Standard Deviation 25.74	39.50 units on a scale Standard Deviation 27.81	58.41 units on a scale Standard Deviation 28.69	46.15 units on a scale Standard Deviation 18.05	55.64 units on a scale Standard Deviation 31.61	57.34 units on a scale Standard Deviation 26.32	57.46 units on a scale Standard Deviation 26.43
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: ASOB (n=40,20,44,13,55,64,59,52,12,34,17	11.15 units on a scale Standard Deviation 18.33	25.00 units on a scale Standard Deviation 32.05	13.53 units on a scale Standard Deviation 15.35	14.12 units on a scale Standard Deviation 25.26	14.00 units on a scale Standard Deviation 17.66	20.00 units on a scale Standard Deviation 26.75	12.73 units on a scale Standard Deviation 18.85	18.46 units on a scale Standard Deviation 17.25	14.18 units on a scale Standard Deviation 20.61	17.19 units on a scale Standard Deviation 23.33	11.53 units on a scale Standard Deviation 19.72
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: SD (n=40,20,44,13,55,64,59,52,12,34,17)	28.49 units on a scale Standard Deviation 23.70	52.19 units on a scale Standard Deviation 29.21	30.33 units on a scale Standard Deviation 24.00	36.40 units on a scale Standard Deviation 27.29	32.31 units on a scale Standard Deviation 19.05	40.19 units on a scale Standard Deviation 21.76	30.80 units on a scale Standard Deviation 24.04	38.08 units on a scale Standard Deviation 28.62	32.77 units on a scale Standard Deviation 25.76	32.73 units on a scale Standard Deviation 26.78	32.61 units on a scale Standard Deviation 26.23
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Opt (n=40,20,44,13,55,64,60,53,12,36,17)	0.57 units on a scale Standard Deviation 0.50	0.33 units on a scale Standard Deviation 0.49	0.58 units on a scale Standard Deviation 0.50	0.41 units on a scale Standard Deviation 0.51	0.53 units on a scale Standard Deviation 0.51	0.50 units on a scale Standard Deviation 0.51	0.55 units on a scale Standard Deviation 0.50	0.38 units on a scale Standard Deviation 0.51	0.45 units on a scale Standard Deviation 0.50	0.55 units on a scale Standard Deviation 0.50	0.45 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Qua (n=40,20,44,13,55,64,59,52,12,34,17)	7.12 units on a scale Standard Deviation 1.20	9.42 units on a scale Standard Deviation 12.87	7.43 units on a scale Standard Deviation 1.09	6.41 units on a scale Standard Deviation 1.42	6.88 units on a scale Standard Deviation 1.44	6.80 units on a scale Standard Deviation 1.40	7.25 units on a scale Standard Deviation 1.31	6.69 units on a scale Standard Deviation 1.65	7.93 units on a scale Standard Deviation 7.26	6.94 units on a scale Standard Deviation 1.23	7.05 units on a scale Standard Deviation 1.85
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Sno (n=40,20,44,13,54,64,59,52,12,34,17)	38.46 units on a scale Standard Deviation 32.62	35.00 units on a scale Standard Deviation 28.44	27.06 units on a scale Standard Deviation 32.62	34.12 units on a scale Standard Deviation 33.74	26.50 units on a scale Standard Deviation 23.70	38.00 units on a scale Standard Deviation 32.38	35.00 units on a scale Standard Deviation 31.73	44.62 units on a scale Standard Deviation 32.82	37.41 units on a scale Standard Deviation 32.05	38.13 units on a scale Standard Deviation 33.37	35.25 units on a scale Standard Deviation 30.25
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: OSP (n=68,0,68,0,68,73,73,79,0,66,0)	36.22 units on a scale Standard Deviation 19.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.67 units on a scale Standard Deviation 18.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.04 units on a scale Standard Deviation 19.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.88 units on a scale Standard Deviation 21.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.74 units on a scale Standard Deviation 20.11	35.65 units on a scale Standard Deviation 19.37	35.27 units on a scale Standard Deviation 20.56
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Som (n=70,0,68,0,71,74,75,78,0,69,0)	35.04 units on a scale Standard Deviation 22.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.04 units on a scale Standard Deviation 20.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.14 units on a scale Standard Deviation 20.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.63 units on a scale Standard Deviation 23.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.86 units on a scale Standard Deviation 19.17	34.50 units on a scale Standard Deviation 19.03	35.91 units on a scale Standard Deviation 22.08
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Ade (n=68,0,68,0,68,73,73,79,0,66,0)	50.51 units on a scale Standard Deviation 27.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.24 units on a scale Standard Deviation 29.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.15 units on a scale Standard Deviation 27.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.56 units on a scale Standard Deviation 28.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	53.24 units on a scale Standard Deviation 31.64	53.42 units on a scale Standard Deviation 25.40	57.53 units on a scale Standard Deviation 28.81
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: ASOB (n=68,0,68,0,68,73,73,79,0,65,0)	20.25 units on a scale Standard Deviation 26.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.88 units on a scale Standard Deviation 23.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.29 units on a scale Standard Deviation 25.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.65 units on a scale Standard Deviation 22.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.94 units on a scale Standard Deviation 22.70	22.74 units on a scale Standard Deviation 24.11	15.34 units on a scale Standard Deviation 21.74
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SD (n=68,0,68,0,68,73,73,79,0,66,0)	35.87 units on a scale Standard Deviation 24.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.33 units on a scale Standard Deviation 25.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.15 units on a scale Standard Deviation 22.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.21 units on a scale Standard Deviation 27.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.00 units on a scale Standard Deviation 23.80	34.93 units on a scale Standard Deviation 24.83	38.73 units on a scale Standard Deviation 26.23
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Som (n=62,0,59,0,63,65,64,70,0,61,0)	30.57 units on a scale Standard Deviation 25.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.96 units on a scale Standard Deviation 18.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.82 units on a scale Standard Deviation 18.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.20 units on a scale Standard Deviation 21.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.01 units on a scale Standard Deviation 23.10	34.36 units on a scale Standard Deviation 23.22	32.29 units on a scale Standard Deviation 20.62
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Opt (n=68,0,68,0,68,73,73,79,0,66,0)	0.44 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.59 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.41 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.43 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.53 units on a scale Standard Deviation 0.50	0.52 units on a scale Standard Deviation 0.50	0.52 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Qua (n=68,0,68,0,68,73,73,79,0,66,0)	6.78 units on a scale Standard Deviation 1.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.08 units on a scale Standard Deviation 1.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.75 units on a scale Standard Deviation 1.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.76 units on a scale Standard Deviation 1.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.72 units on a scale Standard Deviation 1.26	7.05 units on a scale Standard Deviation 1.30	7.10 units on a scale Standard Deviation 1.70
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Sno (n=68,0,67,0,68,73,73,79,0,66,0)	30.63 units on a scale Standard Deviation 30.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.76 units on a scale Standard Deviation 35.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.94 units on a scale Standard Deviation 29.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.59 units on a scale Standard Deviation 32.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.01 units on a scale Standard Deviation 31.38	35.62 units on a scale Standard Deviation 33.21	30.96 units on a scale Standard Deviation 33.01
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Som (n=67,0,68,0,68,73,73,79,0,66,0)	31.73 units on a scale Standard Deviation 22.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.51 units on a scale Standard Deviation 20.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.34 units on a scale Standard Deviation 21.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.63 units on a scale Standard Deviation 24.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.08 units on a scale Standard Deviation 21.66	33.79 units on a scale Standard Deviation 20.97	32.69 units on a scale Standard Deviation 21.26
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SPS (n=62,0,59,0,63,65,64,70,0,61,0)	32.81 units on a scale Standard Deviation 21.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.26 units on a scale Standard Deviation 22.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.05 units on a scale Standard Deviation 16.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.62 units on a scale Standard Deviation 22.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.39 units on a scale Standard Deviation 20.64	34.92 units on a scale Standard Deviation 18.85	35.00 units on a scale Standard Deviation 19.41
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: OSP (n=62,0,59,0,63,65,64,70,0,61,0)	33.44 units on a scale Standard Deviation 21.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.50 units on a scale Standard Deviation 20.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.78 units on a scale Standard Deviation 16.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.23 units on a scale Standard Deviation 20.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.61 units on a scale Standard Deviation 19.83	35.26 units on a scale Standard Deviation 19.48	36.33 units on a scale Standard Deviation 19.86
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Ade (n=62,0,59,0,63,65,64,70,0,61,0)	58.43 units on a scale Standard Deviation 27.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.59 units on a scale Standard Deviation 27.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.35 units on a scale Standard Deviation 24.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.92 units on a scale Standard Deviation 32.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	53.17 units on a scale Standard Deviation 29.99	54.00 units on a scale Standard Deviation 26.74	56.09 units on a scale Standard Deviation 28.21
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: ASOB (n=62,0,59,0,63,65,64,70,0,61,0)	21.43 units on a scale Standard Deviation 26.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.98 units on a scale Standard Deviation 28.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.16 units on a scale Standard Deviation 22.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.90 units on a scale Standard Deviation 19.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.32 units on a scale Standard Deviation 27.24	20.00 units on a scale Standard Deviation 23.72	18.75 units on a scale Standard Deviation 22.50
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SD (n=62,0,59,0,63,65,64,70,0,61,0)	34.18 units on a scale Standard Deviation 27.10	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.41 units on a scale Standard Deviation 26.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.94 units on a scale Standard Deviation 20.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.66 units on a scale Standard Deviation 26.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.52 units on a scale Standard Deviation 23.96	34.27 units on a scale Standard Deviation 25.00	39.16 units on a scale Standard Deviation 25.16
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Opt (n=63,0,59,0,64,65,65,70,0,61,0)	0.51 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.48 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.52 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.53 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.48 units on a scale Standard Deviation 0.50	0.54 units on a scale Standard Deviation 0.50	0.45 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Qua (n=62,0,58,0,63,65,64,70,0,61,0)	7.60 units on a scale Standard Deviation 5.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.10 units on a scale Standard Deviation 9.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.08 units on a scale Standard Deviation 1.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.05 units on a scale Standard Deviation 1.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.71 units on a scale Standard Deviation 1.49	6.85 units on a scale Standard Deviation 1.33	6.98 units on a scale Standard Deviation 1.74
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Sno (n=61,0,59,0,63,65,64,70,0,61,0)	33.43 units on a scale Standard Deviation 29.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.82 units on a scale Standard Deviation 31.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.18 units on a scale Standard Deviation 26.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.92 units on a scale Standard Deviation 32.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.59 units on a scale Standard Deviation 32.19	35.69 units on a scale Standard Deviation 32.11	34.69 units on a scale Standard Deviation 32.71
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: SPS (n=40,20,44,13,55,64,59,52,12,34,17)	25.45 units on a scale Standard Deviation 17.75	44.44 units on a scale Standard Deviation 27.09	29.51 units on a scale Standard Deviation 19.04	32.55 units on a scale Standard Deviation 22.31	32.17 units on a scale Standard Deviation 17.35	43.67 units on a scale Standard Deviation 20.23	30.68 units on a scale Standard Deviation 21.02	38.21 units on a scale Standard Deviation 17.46	32.55 units on a scale Standard Deviation 22.35	32.50 units on a scale Standard Deviation 18.22	29.89 units on a scale Standard Deviation 18.91
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: OSP (n=40,20,44,13,55,64,59,52,12,34,17)	26.76 units on a scale Standard Deviation 17.75	47.27 units on a scale Standard Deviation 27.08	30.41 units on a scale Standard Deviation 18.52	33.04 units on a scale Standard Deviation 21.93	31.64 units on a scale Standard Deviation 16.38	42.86 units on a scale Standard Deviation 19.06	31.46 units on a scale Standard Deviation 19.54	38.80 units on a scale Standard Deviation 18.07	32.18 units on a scale Standard Deviation 21.24	32.95 units on a scale Standard Deviation 18.88	31.18 units on a scale Standard Deviation 19.77
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Som (n=40,20,44,13,55,64,59,52,12,34,17)	26.03 units on a scale Standard Deviation 21.42	33.89 units on a scale Standard Deviation 25.34	27.06 units on a scale Standard Deviation 17.67	23.14 units on a scale Standard Deviation 18.12	29.50 units on a scale Standard Deviation 19.33	40.67 units on a scale Standard Deviation 20.85	34.39 units on a scale Standard Deviation 25.39	31.79 units on a scale Standard Deviation 18.49	29.94 units on a scale Standard Deviation 20.68	32.40 units on a scale Standard Deviation 24.05	28.70 units on a scale Standard Deviation 19.93

SECONDARY outcome

Timeframe: Baseline, Week 2, 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=67 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=20 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=72 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Ade (n=68,0,68,0,68,73,72,79,0,66,0)	-0.51 units on a scale Standard Deviation 28.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.18 units on a scale Standard Deviation 19.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.68 units on a scale Standard Deviation 22.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.74 units on a scale Standard Deviation 21.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.76 units on a scale Standard Deviation 25.06	3.70 units on a scale Standard Deviation 26.11	7.64 units on a scale Standard Deviation 16.74
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: ASOB (n=68,0,68,0,68,73,73,79,0,66,0)	0.00 units on a scale Standard Deviation 20.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.76 units on a scale Standard Deviation 25.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.29 units on a scale Standard Deviation 19.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.29 units on a scale Standard Deviation 20.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.29 units on a scale Standard Deviation 25.27	5.48 units on a scale Standard Deviation 21.15	-6.03 units on a scale Standard Deviation 21.78
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: ASOB (n=40,20,44,13,55,64,59,52,12,34,17)	-5.38 units on a scale Standard Deviation 19.45	-6.67 units on a scale Standard Deviation 21.46	-11.18 units on a scale Standard Deviation 21.57	3.53 units on a scale Standard Deviation 26.68	-3.50 units on a scale Standard Deviation 20.20	-7.00 units on a scale Standard Deviation 29.22	-11.36 units on a scale Standard Deviation 27.42	-1.54 units on a scale Standard Deviation 26.41	-3.27 units on a scale Standard Deviation 24.27	0.63 units on a scale Standard Deviation 24.94	-10.17 units on a scale Standard Deviation 25.56
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Opt (n=40,20,44,13,55,64,60,53,12,36,17)	0.02 units on a scale Standard Deviation 0.54	0.00 units on a scale Standard Deviation 0.74	-0.08 units on a scale Standard Deviation 0.60	-0.06 units on a scale Standard Deviation 0.56	0.00 units on a scale Standard Deviation 0.51	0.00 units on a scale Standard Deviation 0.65	0.07 units on a scale Standard Deviation 0.62	-0.08 units on a scale Standard Deviation 0.64	0.02 units on a scale Standard Deviation 0.62	0.08 units on a scale Standard Deviation 0.65	-0.05 units on a scale Standard Deviation 0.53
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Qua (n=40,20,43,13,55,64,59,51,11,35,17)	0.08 units on a scale Standard Deviation 1.04	3.36 units on a scale Standard Deviation 13.89	0.29 units on a scale Standard Deviation 1.45	0.24 units on a scale Standard Deviation 1.25	-0.10 units on a scale Standard Deviation 1.26	0.00 units on a scale Standard Deviation 1.65	0.35 units on a scale Standard Deviation 1.56	0.38 units on a scale Standard Deviation 1.66	0.33 units on a scale Standard Deviation 2.13	-0.42 units on a scale Standard Deviation 3.97	0.31 units on a scale Standard Deviation 1.44
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Sno (n=40,19,44,13,54,64,59,52,12,34,17)	1.54 units on a scale Standard Deviation 28.79	5.00 units on a scale Standard Deviation 30.90	-6.47 units on a scale Standard Deviation 26.84	-1.18 units on a scale Standard Deviation 11.11	3.50 units on a scale Standard Deviation 25.17	-1.05 units on a scale Standard Deviation 23.55	2.73 units on a scale Standard Deviation 28.48	6.15 units on a scale Standard Deviation 18.95	-7.04 units on a scale Standard Deviation 24.92	0.31 units on a scale Standard Deviation 28.84	2.37 units on a scale Standard Deviation 22.92
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Som (n=40,20,44,13,55,64,59,51,11,34,17)	-6.80 units on a scale Standard Deviation 21.19	-4.24 units on a scale Standard Deviation 18.68	-7.06 units on a scale Standard Deviation 17.36	-2.35 units on a scale Standard Deviation 15.45	-5.33 units on a scale Standard Deviation 21.94	0.67 units on a scale Standard Deviation 18.34	-2.58 units on a scale Standard Deviation 20.29	-4.10 units on a scale Standard Deviation 15.04	-2.18 units on a scale Standard Deviation 21.08	-1.04 units on a scale Standard Deviation 20.03	-6.55 units on a scale Standard Deviation 20.02
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Opt (n=68,0,68,0,68,73,73,79,0,66,0)	-0.05 units on a scale Standard Deviation 0.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.08 units on a scale Standard Deviation 0.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.10 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.01 units on a scale Standard Deviation 0.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.04 units on a scale Standard Deviation 0.44	0.07 units on a scale Standard Deviation 0.56	0.04 units on a scale Standard Deviation 0.54
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Qua (n=68,0,67,0,68,73,73,77,0,66,0)	-0.09 units on a scale Standard Deviation 1.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.36 units on a scale Standard Deviation 0.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.13 units on a scale Standard Deviation 1.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.03 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.69 units on a scale Standard Deviation 7.75	-0.21 units on a scale Standard Deviation 3.75	0.41 units on a scale Standard Deviation 1.21
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Sno (n=67,0,68,0,67,73,73,79,0,66,0)	-4.05 units on a scale Standard Deviation 23.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.91 units on a scale Standard Deviation 23.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.28 units on a scale Standard Deviation 22.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.29 units on a scale Standard Deviation 22.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.46 units on a scale Standard Deviation 21.97	-4.66 units on a scale Standard Deviation 23.46	-4.11 units on a scale Standard Deviation 21.33
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Som (n=67,0,68,0,68,73,73,77,0,66,0)	-3.03 units on a scale Standard Deviation 17.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.22 units on a scale Standard Deviation 18.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.18 units on a scale Standard Deviation 18.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.00 units on a scale Standard Deviation 18.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.37 units on a scale Standard Deviation 18.05	-0.73 units on a scale Standard Deviation 16.20	-2.74 units on a scale Standard Deviation 15.79
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: SPS (n=62,0,59,0,63,65,63,70,0,61,0)	-4.62 units on a scale Standard Deviation 17.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.95 units on a scale Standard Deviation 18.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.54 units on a scale Standard Deviation 12.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.51 units on a scale Standard Deviation 20.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.97 units on a scale Standard Deviation 18.57	-2.00 units on a scale Standard Deviation 19.98	-5.19 units on a scale Standard Deviation 19.19
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: OSP (n=62,0,59,0,63,65,63,69,0,61,0)	-6.42 units on a scale Standard Deviation 15.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.03 units on a scale Standard Deviation 17.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.27 units on a scale Standard Deviation 11.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.21 units on a scale Standard Deviation 18.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.59 units on a scale Standard Deviation 18.71	-3.64 units on a scale Standard Deviation 18.32	-5.63 units on a scale Standard Deviation 17.18
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Ade (n=62,0,59,0,63,65,63,70,0,61,0)	6.57 units on a scale Standard Deviation 32.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.82 units on a scale Standard Deviation 23.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.45 units on a scale Standard Deviation 22.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.19 units on a scale Standard Deviation 27.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.87 units on a scale Standard Deviation 27.51	4.77 units on a scale Standard Deviation 29.32	6.51 units on a scale Standard Deviation 25.15
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: ASOB (n=62,0,59,0,63,65,64,70,0,61,0)	1.43 units on a scale Standard Deviation 24.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.97 units on a scale Standard Deviation 25.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.87 units on a scale Standard Deviation 24.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.46 units on a scale Standard Deviation 24.89	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.81 units on a scale Standard Deviation 28.70	2.46 units on a scale Standard Deviation 26.10	-2.81 units on a scale Standard Deviation 23.87
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: SD (n=62,0,59,0,63,65,64,70,0,61,0)	-8.45 units on a scale Standard Deviation 18.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.97 units on a scale Standard Deviation 21.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.74 units on a scale Standard Deviation 16.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.43 units on a scale Standard Deviation 22.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.25 units on a scale Standard Deviation 23.07	-6.73 units on a scale Standard Deviation 22.54	-8.22 units on a scale Standard Deviation 20.59
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Opt (n=63,0,59,0,64,65,65,70,0,61,0)	0.01 units on a scale Standard Deviation 0.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.08 units on a scale Standard Deviation 0.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 units on a scale Standard Deviation 0.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.07 units on a scale Standard Deviation 0.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.03 units on a scale Standard Deviation 0.64	0.08 units on a scale Standard Deviation 0.62	-0.05 units on a scale Standard Deviation 0.57
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Qua (n=62,0,57,0,63,65,64,68,0,61,0)	0.74 units on a scale Standard Deviation 5.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.33 units on a scale Standard Deviation 9.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.16 units on a scale Standard Deviation 1.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.40 units on a scale Standard Deviation 1.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.73 units on a scale Standard Deviation 8.24	-0.42 units on a scale Standard Deviation 3.80	0.28 units on a scale Standard Deviation 1.52
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Sno (n=61,0,59,0,63,65,64,70,0,61,0)	-1.14 units on a scale Standard Deviation 22.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.28 units on a scale Standard Deviation 19.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.66 units on a scale Standard Deviation 22.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.34 units on a scale Standard Deviation 27.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.54 units on a scale Standard Deviation 28.85	-2.15 units on a scale Standard Deviation 26.25	1.56 units on a scale Standard Deviation 24.25
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Som (n=62,0,59,0,63,65,64,68,0,61,0)	-4.90 units on a scale Standard Deviation 20.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.37 units on a scale Standard Deviation 21.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.56 units on a scale Standard Deviation 18.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.33 units on a scale Standard Deviation 19.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.06 units on a scale Standard Deviation 19.20	1.54 units on a scale Standard Deviation 23.06	-2.81 units on a scale Standard Deviation 20.33
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: SPS (n=40,20,44,13,55,64,58,52,12,34,17)	-7.82 units on a scale Standard Deviation 18.23	-3.33 units on a scale Standard Deviation 20.84	-6.27 units on a scale Standard Deviation 19.96	-2.16 units on a scale Standard Deviation 16.71	-8.25 units on a scale Standard Deviation 15.47	-0.50 units on a scale Standard Deviation 15.83	-11.97 units on a scale Standard Deviation 19.23	-6.92 units on a scale Standard Deviation 18.13	-4.12 units on a scale Standard Deviation 20.03	-3.33 units on a scale Standard Deviation 16.38	-8.62 units on a scale Standard Deviation 18.34
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: OSP (n=40,20,44,13,55,64,58,51,12,34,17)	-9.24 units on a scale Standard Deviation 18.00	-3.38 units on a scale Standard Deviation 18.83	-6.01 units on a scale Standard Deviation 18.67	-1.96 units on a scale Standard Deviation 18.70	-10.18 units on a scale Standard Deviation 14.38	-2.81 units on a scale Standard Deviation 14.39	-12.16 units on a scale Standard Deviation 17.87	-8.50 units on a scale Standard Deviation 16.00	-6.04 units on a scale Standard Deviation 19.83	-4.83 units on a scale Standard Deviation 16.17	-9.82 units on a scale Standard Deviation 16.06
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Ade (n=40,20,44,13,55,64,58,52,12,34,17)	11.92 units on a scale Standard Deviation 32.36	-1.67 units on a scale Standard Deviation 39.73	-1.18 units on a scale Standard Deviation 29.72	8.82 units on a scale Standard Deviation 19.00	7.75 units on a scale Standard Deviation 26.36	-6.00 units on a scale Standard Deviation 25.42	11.59 units on a scale Standard Deviation 24.30	9.23 units on a scale Standard Deviation 23.97	8.00 units on a scale Standard Deviation 28.11	6.72 units on a scale Standard Deviation 29.33	5.52 units on a scale Standard Deviation 26.70
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: SD (n=40,20,44,13,55,64,59,52,12,34,17)	-8.94 units on a scale Standard Deviation 22.39	-7.19 units on a scale Standard Deviation 18.41	-7.06 units on a scale Standard Deviation 23.78	-1.18 units on a scale Standard Deviation 27.63	-13.66 units on a scale Standard Deviation 18.64	-6.31 units on a scale Standard Deviation 17.76	-15.88 units on a scale Standard Deviation 24.63	-13.75 units on a scale Standard Deviation 21.22	-6.59 units on a scale Standard Deviation 25.51	-6.64 units on a scale Standard Deviation 22.53	-13.98 units on a scale Standard Deviation 18.70
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: SPS (n=67,0,68,0,68,73,72,79,0,66,0)	-2.36 units on a scale Standard Deviation 17.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.29 units on a scale Standard Deviation 13.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.95 units on a scale Standard Deviation 11.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.57 units on a scale Standard Deviation 15.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.43 units on a scale Standard Deviation 16.51	-2.05 units on a scale Standard Deviation 14.11	-7.45 units on a scale Standard Deviation 11.74
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: OSP (n=67,0,68,0,68,73,72,78,0,65,0)	-4.07 units on a scale Standard Deviation 15.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.30 units on a scale Standard Deviation 12.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.94 units on a scale Standard Deviation 10.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.76 units on a scale Standard Deviation 14.28	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.93 units on a scale Standard Deviation 14.92	-3.75 units on a scale Standard Deviation 12.36	-7.06 units on a scale Standard Deviation 10.93
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: SD (n=68,0,68,0,68,73,73,79,0,65,0)	-7.85 units on a scale Standard Deviation 20.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.81 units on a scale Standard Deviation 17.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.64 units on a scale Standard Deviation 13.23	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.89 units on a scale Standard Deviation 17.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.82 units on a scale Standard Deviation 18.04	-6.73 units on a scale Standard Deviation 15.61	-8.77 units on a scale Standard Deviation 15.11

SECONDARY outcome

Timeframe: Baseline, Week 2, 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Outcome measures

Measure	CP-690,550 20 mg n=79 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=69 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=70 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=71 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=73 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=75 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 12 (n=61,0,59,0,63,65,64,69,0,61,0)	33.99 units on a scale Standard Deviation 11.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.42 units on a scale Standard Deviation 10.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.25 units on a scale Standard Deviation 10.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.44 units on a scale Standard Deviation 11.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.30 units on a scale Standard Deviation 10.87	33.17 units on a scale Standard Deviation 9.43	35.05 units on a scale Standard Deviation 10.17
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline (n=70,0,68,0,71,73,75,79,0,69,0)	29.76 units on a scale Standard Deviation 11.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.23 units on a scale Standard Deviation 11.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.17 units on a scale Standard Deviation 10.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.92 units on a scale Standard Deviation 11.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.76 units on a scale Standard Deviation 10.42	30.06 units on a scale Standard Deviation 10.85	29.48 units on a scale Standard Deviation 10.19
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 2 (n=68,0,68,0,68,73,73,78,0,66,0)	33.36 units on a scale Standard Deviation 10.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.88 units on a scale Standard Deviation 8.90	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.41 units on a scale Standard Deviation 12.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.65 units on a scale Standard Deviation 10.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.46 units on a scale Standard Deviation 11.78	32.51 units on a scale Standard Deviation 10.58	33.41 units on a scale Standard Deviation 10.10
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 24 (n=39,20,44,13,55,64,59,51,12,35,17)	38.24 units on a scale Standard Deviation 9.46	29.50 units on a scale Standard Deviation 12.27	37.17 units on a scale Standard Deviation 10.12	37.47 units on a scale Standard Deviation 9.87	36.69 units on a scale Standard Deviation 10.42	28.08 units on a scale Standard Deviation 11.07	35.48 units on a scale Standard Deviation 11.66	34.92 units on a scale Standard Deviation 9.40	36.78 units on a scale Standard Deviation 10.75	35.36 units on a scale Standard Deviation 10.01	36.80 units on a scale Standard Deviation 9.85

SECONDARY outcome

Timeframe: Baseline, Week 2, 12, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.

FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Outcome measures

Measure	CP-690,550 20 mg n=78 Participants CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=66 Participants Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=17 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg n=68 Participants CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 Participants Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=68 Participants CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 Participants Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=68 Participants CP-690,550 5 mg tablet orally twice daily for 24 weeks.	CP-690,550 10 mg n=72 Participants CP-690,550 10 mg tablet orally twice daily for 24 weeks.	CP-690,550 15 mg n=73 Participants CP-690,550 15 mg tablet orally twice daily for 24 weeks.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 2 (n=68,0,68,0,68,72,73,78,0,66,0)	3.37 units on a scale Standard Deviation 6.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.61 units on a scale Standard Deviation 6.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.96 units on a scale Standard Deviation 7.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.74 units on a scale Standard Deviation 7.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.54 units on a scale Standard Deviation 7.71	2.80 units on a scale Standard Deviation 7.40	3.68 units on a scale Standard Deviation 7.24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 12 (n=61,0,59,0,63,65,64,69,0,61,0)	4.51 units on a scale Standard Deviation 9.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.71 units on a scale Standard Deviation 9.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.82 units on a scale Standard Deviation 8.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.79 units on a scale Standard Deviation 10.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.90 units on a scale Standard Deviation 8.98	2.18 units on a scale Standard Deviation 9.25	5.41 units on a scale Standard Deviation 9.02
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 24 (n=39,20,44,13,55,64,59,50,12,35,17)	6.88 units on a scale Standard Deviation 9.28	4.75 units on a scale Standard Deviation 10.84	3.23 units on a scale Standard Deviation 12.13	4.18 units on a scale Standard Deviation 6.09	6.23 units on a scale Standard Deviation 9.66	3.73 units on a scale Standard Deviation 10.35	5.33 units on a scale Standard Deviation 9.42	5.62 units on a scale Standard Deviation 11.57	7.18 units on a scale Standard Deviation 9.08	4.49 units on a scale Standard Deviation 9.43	6.54 units on a scale Standard Deviation 8.90

Adverse Events

CP-690,550 1 mg

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

CP-690,550 1 mg to CP-690,550 5 mg (R)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

CP-690,550 3 mg

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

CP-690,550 3 mg to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CP-690,550 5 mg

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

CP-690,550 15 mg

Serious events: 6 serious events

Other events: 46 other events

Deaths: 0 deaths

CP-690,550 20 mg

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

CP-690,550 20 mg to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	CP-690,550 1 mg n=49 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.	CP-690,550 3 mg n=55 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.	CP-690,550 5 mg n=71 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 10 mg n=74 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 24.	CP-690,550 15 mg n=75 participants at risk CP-690,550 15 mg tablet orally twice daily up to Week 24.	CP-690,550 20 mg n=67 participants at risk CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=13 participants at risk CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=51 participants at risk Matching placebo tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) n=18 participants at risk Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
General disorders Chest pain	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure congestive	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Blindness	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Food poisoning	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastric ulcer	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Dissociative disorder	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Circulatory collapse	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	CP-690,550 1 mg n=49 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 24.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=21 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.	CP-690,550 3 mg n=55 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=13 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.	CP-690,550 5 mg n=71 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 10 mg n=74 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 24.	CP-690,550 15 mg n=75 participants at risk CP-690,550 15 mg tablet orally twice daily up to Week 24.	CP-690,550 20 mg n=67 participants at risk CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.	CP-690,550 20 mg to CP-690,550 5 mg (R) n=13 participants at risk CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=51 participants at risk Matching placebo tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) n=18 participants at risk Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
General disorders Chest pain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Bradycardia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Extrasystoles	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Palpitations	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Visual disturbance	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Xerophthalmia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 2/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 3/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Breath odour	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	14.3% 7/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.7% 9/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 3/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 2/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 2/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 3/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.2% 3/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 5/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 4/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomach discomfort	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.2% 3/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 2/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Irritability	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.2% 3/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Allergy to arthropod bite	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Ear infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 4/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Nervousness	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes simplex	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 5/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 3/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Laryngitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.0% 5/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.0% 6/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 3/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Onychomycosis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral fungal infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.5% 2/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Parainfluenzae virus infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 3/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 2/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis streptococcal	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngotonsillitis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pulpitis dental	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis bacterial	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tinea cruris	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tinea pedis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tracheitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.0% 5/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 5/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 2/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.0% 5/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 4/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 5/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Animal bite	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Excoriation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fibula fracture	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Foot fracture	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Injury	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 5/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.7% 5/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood cholesterol increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram ST-T change	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram T wave abnormal	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram abnormal	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haematocrit decreased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Hepatic enzyme increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight increased	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 4/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperlipidaemia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Fibromyalgia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Burning sensation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cluster headache	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 4/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.4% 9/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypersomnia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sciatica	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sinus headache	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tension headache	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Emotional disorder	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Nightmare	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Leukocyturia	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pyuria	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Genital discharge	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Ovarian cyst	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.2% 3/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.1% 6/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palpable purpura	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 2/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 4/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash papular	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	2.0% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 1/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	4.1% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.8% 1/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 1/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Venous stasis	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/21 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/71 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/75 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/18 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject 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: ClinicalTrials.gov_Inquiries@pfizer.com

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