Trial Outcomes & Findings for A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis (NCT NCT01309737)

NCT ID: NCT01309737

Last Updated: 2014-09-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

960 participants

Primary outcome timeframe

Week 16

Results posted on

2014-09-19

Participant Flow

Outcome measures reporting results up to Week 16 consist of single placebo arm as reporting group while outcome measures reporting results up to Week 52 consist of 2 separate arms (for participants re-randomized at Week 16 to receive CP-690,550 5 milligram \[mg\] or 10 mg).

Participant milestones

Participant milestones
Measure	CP-690,550 5mg CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, CP-690,550 5 mg Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.	Placebo,CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Week 0 to 16 STARTED	383	381	196	0	0
Week 0 to 16 Treated	382	381	196	0	0
Week 0 to 16 COMPLETED	331	341	152	0	0
Week 0 to 16 NOT COMPLETED	52	40	44	0	0
Week 16 to 52 STARTED	331	341	0	75	77
Week 16 to 52 COMPLETED	198	238	0	41	44
Week 16 to 52 NOT COMPLETED	133	103	0	34	33

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 5mg CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, CP-690,550 5 mg Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.	Placebo,CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Week 0 to 16 Death	1	0	1	0	0
Week 0 to 16 Adverse Event	11	10	5	0	0
Week 0 to 16 Lack of Efficacy	15	2	24	0	0
Week 0 to 16 Lost to Follow-up	7	8	3	0	0
Week 0 to 16 Withdrawal by Subject	7	6	7	0	0
Week 0 to 16 Other	10	14	4	0	0
Week 0 to 16 Randomized, but not treated	1	0	0	0	0
Week 16 to 52 Death	0	0	0	0	1
Week 16 to 52 Adverse Event	7	7	0	6	5
Week 16 to 52 Lack of Efficacy	107	76	0	25	21
Week 16 to 52 Lost to Follow-up	4	2	0	1	4
Week 16 to 52 Withdrawal by Subject	5	6	0	0	2
Week 16 to 52 Other	10	12	0	2	0

Baseline Characteristics

A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 5mg n=382 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=381 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=196 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Total n=959 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 12.9 • n=93 Participants	44.3 years STANDARD_DEVIATION 13.0 • n=4 Participants	44.8 years STANDARD_DEVIATION 12.6 • n=27 Participants	45.0 years STANDARD_DEVIATION 12.9 • n=483 Participants
Sex: Female, Male Female	114 Participants n=93 Participants	124 Participants n=4 Participants	73 Participants n=27 Participants	311 Participants n=483 Participants
Sex: Female, Male Male	268 Participants n=93 Participants	257 Participants n=4 Participants	123 Participants n=27 Participants	648 Participants n=483 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS): participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to good clinical practices(GCP) compliance issues. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16	46.01 percentage of participants	59.09 percentage of participants	10.88 percentage of participants	—

PRIMARY outcome

Timeframe: Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16	46.01 percentage of participants	59.63 percentage of participants	11.40 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP non-compliance. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage \[Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)\]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=188 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16	-54.86 percent change Standard Error 2.12	-67.22 percent change Standard Error 2.11	-9.12 percent change Standard Error 3.02	—

SECONDARY outcome

Timeframe: Week 16

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16	24.47 percentage of participants	38.77 percentage of participants	5.18 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=371 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Dermatology Life Quality Index (DLQI) Total Score	13.22 units on a scale Standard Deviation 7.21	12.69 units on a scale Standard Deviation 7.18	13.19 units on a scale Standard Deviation 7.35	—

SECONDARY outcome

Timeframe: Baseline, Week 4,16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=372 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=368 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=188 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 Change at Week 4	-5.55 units on a scale Standard Error 0.24	-6.88 units on a scale Standard Error 0.25	-2.57 units on a scale Standard Error 0.35	—
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 Change at Week 16	-7.28 units on a scale Standard Error 0.30	-8.92 units on a scale Standard Error 0.31	-2.82 units on a scale Standard Error 0.44	—

SECONDARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4	17.02 percentage of participants	27.81 percentage of participants	5.18 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4	7.45 percentage of participants	14.17 percentage of participants	4.15 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study, received at least 1 dose investigational drug. Participants from 1 site were excluded due to GCP compliance issues. 'N' (number of participants analyzed) were participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.

The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=227 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=216 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=109 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16	-21.62 percent change Standard Error 7.65	-25.97 percent change Standard Error 7.87	15.82 percent change Standard Error 11.27	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=171 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=215 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52	63.55 percent probability of response Interval 55.67 to 70.4	71.71 percent probability of response Interval 65.12 to 77.28	—	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.

The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=171 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=217 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52	74.38 percent probability of response Interval 66.94 to 80.39	78.99 percent probability of response Interval 72.8 to 83.92	—	—

SECONDARY outcome

Timeframe: Week 52

Population: FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.

The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=92 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=140 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52	70.33 percent probability of response Interval 59.79 to 78.6	63.83 percent probability of response Interval 55.21 to 71.23	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=372 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=188 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	12.0 weeks Interval 12.0 to 16.0	8.0 weeks Interval 8.0 to 12.0	NA weeks Data was not estimable because estimated probability of response by Week 16 was less than 50%.	—

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=188 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response	16.0 weeks Interval 16.0 to Data was not estimable because estimated probability of response by Week 16 was less than 50%.	12.0 weeks Upper and lower limits were not estimable based on the log-log transformation method.	NA weeks Data was not estimable because estimated probability of response by Week 16 was less than 50%.	—

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=188 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response	8.0 weeks Interval 8.0 to 12.0	8.0 weeks Upper and lower limits were not estimable based on the log-log transformation method.	NA weeks Data was not estimable because estimated probability of response by Week 16 was less than 50%.	—

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 4	17.02 percentage of participants Interval 13.22 to 20.82	27.81 percentage of participants Interval 23.27 to 32.35	6.76 percentage of participants Interval 1.04 to 12.48	5.26 percentage of participants Interval 0.24 to 10.28
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 2	5.32 percentage of participants Interval 3.05 to 7.59	9.63 percentage of participants Interval 6.64 to 12.61	2.70 percentage of participants Interval 0.0 to 6.4	3.95 percentage of participants Interval 0.0 to 8.33
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 8	33.51 percentage of participants Interval 28.74 to 38.28	49.20 percentage of participants Interval 44.13 to 54.26	12.16 percentage of participants Interval 4.72 to 19.61	7.89 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 12	41.49 percentage of participants Interval 36.51 to 46.47	55.35 percentage of participants Interval 50.31 to 60.39	14.86 percentage of participants Interval 6.76 to 22.97	7.89 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 16	46.01 percentage of participants Interval 40.97 to 51.05	59.09 percentage of participants Interval 54.11 to 64.07	17.57 percentage of participants Interval 8.9 to 26.24	9.21 percentage of participants Interval 2.71 to 15.71
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 20	47.34 percentage of participants Interval 42.29 to 52.39	59.09 percentage of participants Interval 54.11 to 64.07	33.78 percentage of participants Interval 23.01 to 44.56	40.79 percentage of participants Interval 29.74 to 51.84
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 28	50.53 percentage of participants Interval 45.48 to 55.59	62.03 percentage of participants Interval 57.11 to 66.95	52.70 percentage of participants Interval 41.33 to 64.08	68.42 percentage of participants Interval 57.97 to 78.87
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 40	42.55 percentage of participants Interval 37.56 to 47.55	55.88 percentage of participants Interval 50.85 to 60.91	43.24 percentage of participants Interval 31.96 to 54.53	59.21 percentage of participants Interval 48.16 to 70.26
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 52	36.97 percentage of participants Interval 32.09 to 41.85	50.00 percentage of participants Interval 44.93 to 55.07	36.49 percentage of participants Interval 25.52 to 47.45	40.79 percentage of participants Interval 29.74 to 51.84

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Severe(n=194,239,38,42)	0 percentage of participants	0.4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Mild(n=354,356,74,76)	34.7 percentage of participants	30.3 percentage of participants	27.0 percentage of participants	32.9 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Moderate(n=354,356,74,76)	26.6 percentage of participants	16.6 percentage of participants	51.4 percentage of participants	52.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Severe(n=354,356,74,76)	3.1 percentage of participants	1.4 percentage of participants	9.5 percentage of participants	6.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Clear(n=376,374,74,76)	0 percentage of participants Interval 3.05 to 7.59	0 percentage of participants Interval 6.64 to 12.61	0 percentage of participants Interval 0.0 to 6.4	0 percentage of participants Interval 0.0 to 8.33
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Almost clear(n=376,374,74,76)	0 percentage of participants Interval 13.22 to 20.82	0 percentage of participants Interval 23.27 to 32.35	0 percentage of participants Interval 1.04 to 12.48	0 percentage of participants Interval 0.24 to 10.28
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Mild(n=376,374,74,76)	0 percentage of participants Interval 28.74 to 38.28	0 percentage of participants Interval 44.13 to 54.26	0 percentage of participants Interval 4.72 to 19.61	0 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Moderate(n=376,374,74,76)	82.4 percentage of participants Interval 36.51 to 46.47	81.6 percentage of participants Interval 50.31 to 60.39	87.8 percentage of participants Interval 6.76 to 22.97	84.2 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Severe(n=376,374,74,76)	17.6 percentage of participants Interval 40.97 to 51.05	18.4 percentage of participants Interval 54.11 to 64.07	12.2 percentage of participants Interval 8.9 to 26.24	15.8 percentage of participants Interval 2.71 to 15.71
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Clear(n=370,367,73,76)	0.3 percentage of participants	0.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Almost clear(n=370,367,73,76)	5.1 percentage of participants	9.5 percentage of participants	2.7 percentage of participants	3.9 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Mild(n=370,367,73,76)	30.5 percentage of participants	31.1 percentage of participants	8.2 percentage of participants	15.8 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Moderate(n=370,367,73,76)	55.4 percentage of participants	51.5 percentage of participants	74.0 percentage of participants	71.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Severe(n=370,367,73,76)	8.6 percentage of participants	7.6 percentage of participants	15.1 percentage of participants	9.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Clear(n=362,366,74,75)	1.7 percentage of participants	2.2 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Almost clear(n=362,366,74,75)	16.0 percentage of participants	26.2 percentage of participants	6.8 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Mild(n=362,366,74,75)	40.3 percentage of participants	39.1 percentage of participants	17.6 percentage of participants	28.0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Moderate(n=362,366,74,75)	38.4 percentage of participants	29.0 percentage of participants	66.2 percentage of participants	61.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Severe(n=362,366,74,75)	3.6 percentage of participants	3.6 percentage of participants	9.5 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Clear(n=354,356,74,76)	7.1 percentage of participants	10.1 percentage of participants	2.7 percentage of participants	2.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Almost clear(n=354,356,74,76)	28.5 percentage of participants	41.6 percentage of participants	9.5 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Clear(n=347,348,74,76)	11.5 percentage of participants	20.1 percentage of participants	5.4 percentage of participants	2.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Almost clear(n=347,348,74,76)	33.4 percentage of participants	39.4 percentage of participants	9.5 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Mild(n=347,348,74,76)	32.6 percentage of participants	26.4 percentage of participants	29.7 percentage of participants	38.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Moderate(n=347,348,74,76)	19.0 percentage of participants	12.6 percentage of participants	47.3 percentage of participants	46.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Severe(n=347,348,74,76)	3.5 percentage of participants	1.4 percentage of participants	8.1 percentage of participants	7.9 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Clear(n=340,345,74,76)	16.5 percentage of participants	27.0 percentage of participants	6.8 percentage of participants	2.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Almost clear(n=340,345,74,76)	34.4 percentage of participants	37.1 percentage of participants	10.8 percentage of participants	6.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Mild(n=340,345,74,76)	27.4 percentage of participants	24.1 percentage of participants	25.7 percentage of participants	38.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16 : Moderate(n=340,345,74,76)	19.1 percentage of participants	9.6 percentage of participants	50.0 percentage of participants	47.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Severe(n=340,345,74,76)	2.6 percentage of participants	2.3 percentage of participants	6.8 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Clear(n=327,338,74,76)	19.3 percentage of participants	30.2 percentage of participants	10.8 percentage of participants	5.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Almost clear(n=327,338,74,76)	35.2 percentage of participants	35.2 percentage of participants	23.0 percentage of participants	35.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Mild(n=327,338,74,76)	29.4 percentage of participants	24.0 percentage of participants	41.9 percentage of participants	40.8 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Moderate(n=327,338,74,76)	15.3 percentage of participants	9.8 percentage of participants	24.3 percentage of participants	18.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Severe(n=327,338,74,76)	0.9 percentage of participants	0.9 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Clear(n=305,328,69,72)	22.6 percentage of participants	30.8 percentage of participants	20.3 percentage of participants	30.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Almost clear(n=305,328,69,72)	39.7 percentage of participants	39.9 percentage of participants	36.2 percentage of participants	41.7 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Mild(n=305,328,69,72)	25.9 percentage of participants	19.2 percentage of participants	23.2 percentage of participants	18.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Moderate(n=305,328,69,72)	10.8 percentage of participants	7.9 percentage of participants	20.3 percentage of participants	9.7 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Severe(n=305,328,69,72)	1.0 percentage of participants	2.1 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Clear(n=213,263,46,55)	34.3 percentage of participants	35.4 percentage of participants	32.6 percentage of participants	38.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Almost clear(n=213,263,46,55)	40.8 percentage of participants	44.1 percentage of participants	37.0 percentage of participants	43.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Mild(n=213,263,46,55)	18.8 percentage of participants	13.7 percentage of participants	21.7 percentage of participants	16.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Moderate(n=213,263,46,55)	5.2 percentage of participants	5.7 percentage of participants	6.5 percentage of participants	1.8 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Severe(n=213,263,46,55)	0.9 percentage of participants	1.1 percentage of participants	2.2 percentage of participants	0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Clear(n=194,239,38,42)	36.1 percentage of participants	39.3 percentage of participants	34.2 percentage of participants	40.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Almost clear(n=194,239,38,42)	35.6 percentage of participants	38.9 percentage of participants	36.8 percentage of participants	33.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Mild(n=194,239,38,42)	22.7 percentage of participants	15.9 percentage of participants	21.1 percentage of participants	21.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Moderate(n=194,239,38,42)	5.7 percentage of participants	5.4 percentage of participants	7.9 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 2	1.33 percentage of participants Interval 0.17 to 2.49	1.87 percentage of participants Interval 0.5 to 3.25	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 4	7.45 percentage of participants Interval 4.79 to 10.1	14.17 percentage of participants Interval 10.64 to 17.71	5.41 percentage of participants Interval 0.25 to 10.56	3.95 percentage of participants Interval 0.0 to 8.33
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 8	24.47 percentage of participants Interval 20.12 to 28.81	39.30 percentage of participants Interval 34.35 to 44.25	8.11 percentage of participants Interval 1.89 to 14.33	5.26 percentage of participants Interval 0.24 to 10.28
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 12	38.56 percentage of participants Interval 33.64 to 43.48	53.48 percentage of participants Interval 48.42 to 58.53	13.51 percentage of participants Interval 5.72 to 21.3	6.58 percentage of participants Interval 1.01 to 12.15
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 16	46.01 percentage of participants Interval 40.97 to 51.05	59.63 percentage of participants Interval 54.65 to 64.6	16.22 percentage of participants Interval 7.82 to 24.61	11.84 percentage of participants Interval 4.58 to 19.11
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 20	49.47 percentage of participants Interval 44.41 to 54.52	62.03 percentage of participants Interval 57.11 to 66.95	32.43 percentage of participants Interval 21.77 to 43.1	38.16 percentage of participants Interval 27.24 to 49.08
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 28	52.13 percentage of participants Interval 47.08 to 57.18	66.31 percentage of participants Interval 61.52 to 71.1	52.70 percentage of participants Interval 41.33 to 64.08	64.47 percentage of participants Interval 53.71 to 75.23
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 40	46.01 percentage of participants Interval 40.97 to 51.05	60.43 percentage of participants Interval 55.47 to 65.38	50.00 percentage of participants Interval 38.61 to 61.39	59.21 percentage of participants Interval 48.16 to 70.26
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 52	42.02 percentage of participants Interval 37.03 to 47.01	52.41 percentage of participants Interval 47.34 to 57.47	41.89 percentage of participants Interval 30.65 to 53.13	44.74 percentage of participants Interval 33.56 to 55.92

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Area and Severity Index (PASI) Score Week 8 (n=354,356,74,76)	10.98 units on a scale Standard Deviation 8.39	8.23 units on a scale Standard Deviation 7.65	17.42 units on a scale Standard Deviation 9.42	18.16 units on a scale Standard Deviation 9.04
Psoriasis Area and Severity Index (PASI) Score Baseline (n=376,374,74,76)	22.96 units on a scale Standard Deviation 8.80	21.88 units on a scale Standard Deviation 8.41	22.58 units on a scale Standard Deviation 8.62	22.36 units on a scale Standard Deviation 8.43
Psoriasis Area and Severity Index (PASI) Score Week 2 (n=369,367,73,76)	18.62 units on a scale Standard Deviation 8.47	17.19 units on a scale Standard Deviation 8.94	21.46 units on a scale Standard Deviation 8.88	19.53 units on a scale Standard Deviation 7.72
Psoriasis Area and Severity Index (PASI) Score Week 4 (n=363,366,74,76)	14.84 units on a scale Standard Deviation 8.27	12.60 units on a scale Standard Deviation 8.44	19.43 units on a scale Standard Deviation 9.35	18.87 units on a scale Standard Deviation 7.86
Psoriasis Area and Severity Index (PASI) Score Week 12 (n=347,348,74,76)	9.22 units on a scale Standard Deviation 8.58	6.39 units on a scale Standard Deviation 7.22	17.07 units on a scale Standard Deviation 10.27	17.29 units on a scale Standard Deviation 8.44
Psoriasis Area and Severity Index (PASI) Score Week 16 (n=340,345,74,76)	8.16 units on a scale Standard Deviation 8.77	5.36 units on a scale Standard Deviation 6.71	16.59 units on a scale Standard Deviation 10.83	16.59 units on a scale Standard Deviation 8.67
Psoriasis Area and Severity Index (PASI) Score Week 20 (n=327,338,74,76)	6.76 units on a scale Standard Deviation 7.71	4.46 units on a scale Standard Deviation 5.83	10.62 units on a scale Standard Deviation 8.71	9.28 units on a scale Standard Deviation 8.20
Psoriasis Area and Severity Index (PASI) Score Week 28 (n=305,327,69,72)	5.62 units on a scale Standard Deviation 6.56	4.15 units on a scale Standard Deviation 6.13	6.71 units on a scale Standard Deviation 7.41	5.38 units on a scale Standard Deviation 8.35
Psoriasis Area and Severity Index (PASI) Score Week 40 (n=213,263,46,55)	3.33 units on a scale Standard Deviation 4.65	2.74 units on a scale Standard Deviation 4.66	4.21 units on a scale Standard Deviation 6.19	2.90 units on a scale Standard Deviation 3.92
Psoriasis Area and Severity Index (PASI) Score Week 52 (n=194,239,38,42)	3.24 units on a scale Standard Deviation 4.16	2.60 units on a scale Standard Deviation 3.89	3.49 units on a scale Standard Deviation 4.13	2.88 units on a scale Standard Deviation 3.56

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. N (number of participants analyzed) signifies the unique participants in the longitudinal model.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 2	-4.09 units on a scale Standard Error 0.28	-4.94 units on a scale Standard Error 0.28	-1.04 units on a scale Standard Error 0.62	-2.87 units on a scale Standard Error 0.61
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 4	-7.87 units on a scale Standard Error 0.34	-9.47 units on a scale Standard Error 0.34	-3.09 units on a scale Standard Error 0.76	-3.65 units on a scale Standard Error 0.75
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 8	-11.68 units on a scale Standard Error 0.40	-13.70 units on a scale Standard Error 0.40	-5.11 units on a scale Standard Error 0.89	-4.23 units on a scale Standard Error 0.87
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 12	-13.35 units on a scale Standard Error 0.42	-15.56 units on a scale Standard Error 0.42	-5.46 units on a scale Standard Error 0.92	-5.10 units on a scale Standard Error 0.91
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 16	-14.23 units on a scale Standard Error 0.44	-16.44 units on a scale Standard Error 0.44	-5.94 units on a scale Standard Error 0.96	-5.80 units on a scale Standard Error 0.95
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 20	-15.54 units on a scale Standard Error 0.41	-17.36 units on a scale Standard Error 0.40	-11.90 units on a scale Standard Error 0.88	-13.12 units on a scale Standard Error 0.87
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 28	-16.50 units on a scale Standard Error 0.41	-17.65 units on a scale Standard Error 0.41	-15.08 units on a scale Standard Error 0.89	-17.14 units on a scale Standard Error 0.89
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 40	-15.84 units on a scale Standard Error 0.46	-16.98 units on a scale Standard Error 0.45	-14.33 units on a scale Standard Error 0.98	-16.42 units on a scale Standard Error 0.96
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 52	-15.40 units on a scale Standard Error 0.47	-16.42 units on a scale Standard Error 0.45	-13.92 units on a scale Standard Error 1.02	-16.16 units on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=374 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=376 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Scaling(Trunk)(n=369,367,73,76)	2.12 units on a scale Standard Deviation 0.95	2.18 units on a scale Standard Deviation 0.92	2.44 units on a scale Standard Deviation 0.96	2.29 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Erythema(Trunk)(n=340,345,74,76)	0.94 units on a scale Standard Deviation 1.06	1.34 units on a scale Standard Deviation 1.16	2.08 units on a scale Standard Deviation 1.11	2.30 units on a scale Standard Deviation 1.03
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Induration(Head\Neck)(n=340,345,74,76)	0.58 units on a scale Standard Deviation 0.86	0.89 units on a scale Standard Deviation 1.04	1.66 units on a scale Standard Deviation 1.06	1.53 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Induration(Upper limbs)(n=340,345,74,76)	1.05 units on a scale Standard Deviation 1.02	1.28 units on a scale Standard Deviation 1.11	2.07 units on a scale Standard Deviation 1.09	2.16 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Scaling(Head\Neck)(n=354,356,74,76)	0.89 units on a scale Standard Deviation 1.05	1.13 units on a scale Standard Deviation 1.10	1.82 units on a scale Standard Deviation 1.06	1.79 units on a scale Standard Deviation 1.10
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Scaling(Upper limbs)(n=363,366,74,75)	1.64 units on a scale Standard Deviation 0.97	1.85 units on a scale Standard Deviation 0.92	2.31 units on a scale Standard Deviation 0.94	2.25 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Scaling(Trunk)(n=363,366,74,75)	1.61 units on a scale Standard Deviation 1.00	1.83 units on a scale Standard Deviation 0.97	2.23 units on a scale Standard Deviation 1.08	2.17 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Scaling(Lower limbs)(n=363,366,74,75)	1.95 units on a scale Standard Deviation 1.00	2.13 units on a scale Standard Deviation 1.00	2.57 units on a scale Standard Deviation 0.88	2.45 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Erythema(Head\Neck)(n=354,356,74,76)	0.96 units on a scale Standard Deviation 1.02	1.24 units on a scale Standard Deviation 1.04	1.85 units on a scale Standard Deviation 1.02	1.79 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Erythema(Upper limbs)(n=354,356,74,76)	1.40 units on a scale Standard Deviation 0.91	1.70 units on a scale Standard Deviation 0.92	2.28 units on a scale Standard Deviation 0.82	2.47 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Erythema(Trunk)(n=354,356,74,76)	1.37 units on a scale Standard Deviation 1.02	1.75 units on a scale Standard Deviation 1.05	2.27 units on a scale Standard Deviation 0.96	2.46 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Erythema(Lower limbs)(n=354,356,74,76)	1.60 units on a scale Standard Deviation 0.99	1.92 units on a scale Standard Deviation 1.04	2.55 units on a scale Standard Deviation 0.88	2.72 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Induration(Head\Neck)(n=354,356,74,76)	0.78 units on a scale Standard Deviation 0.94	1.05 units on a scale Standard Deviation 1.04	1.62 units on a scale Standard Deviation 1.00	1.64 units on a scale Standard Deviation 1.07
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Induration(Upper limbs)(n=354,356,74,76)	1.29 units on a scale Standard Deviation 0.96	1.59 units on a scale Standard Deviation 0.97	2.14 units on a scale Standard Deviation 0.85	2.33 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Induration(Trunk)(n=354,356,74,76)	1.21 units on a scale Standard Deviation 1.03	1.54 units on a scale Standard Deviation 1.05	2.09 units on a scale Standard Deviation 0.97	2.26 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Induration(Lower limbs)(n=354,356,74,76)	1.40 units on a scale Standard Deviation 1.00	1.71 units on a scale Standard Deviation 1.03	2.42 units on a scale Standard Deviation 0.92	2.51 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Scaling(Upper limbs)(n=354,356,74,76)	1.29 units on a scale Standard Deviation 1.01	1.53 units on a scale Standard Deviation 1.00	2.18 units on a scale Standard Deviation 0.93	2.20 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Scaling(Trunk)(n=354,356,74,76)	1.11 units on a scale Standard Deviation 1.05	1.42 units on a scale Standard Deviation 1.07	2.03 units on a scale Standard Deviation 1.06	2.14 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 8:Scaling(Lower limbs)(n=354,356,74,76)	1.36 units on a scale Standard Deviation 1.08	1.68 units on a scale Standard Deviation 1.11	2.34 units on a scale Standard Deviation 0.98	2.41 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Erythema(Head\Neck)(n=347,348,74,76)	0.78 units on a scale Standard Deviation 0.96	1.10 units on a scale Standard Deviation 1.05	1.86 units on a scale Standard Deviation 1.09	1.93 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Erythema(Upper limbs)(n=347,348,74,76)	1.19 units on a scale Standard Deviation 0.92	1.49 units on a scale Standard Deviation 0.97	2.18 units on a scale Standard Deviation 0.88	2.29 units on a scale Standard Deviation 0.98
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Erythema(Trunk)(n=347,348,74,76)	1.11 units on a scale Standard Deviation 1.03	1.52 units on a scale Standard Deviation 1.13	2.24 units on a scale Standard Deviation 1.00	2.38 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Erythema(Lower limbs)(n=347,348,74,76)	1.32 units on a scale Standard Deviation 1.05	1.72 units on a scale Standard Deviation 1.09	2.50 units on a scale Standard Deviation 0.93	2.61 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Induration(Head\Neck)(n=347,348,74,76)	0.63 units on a scale Standard Deviation 0.90	0.93 units on a scale Standard Deviation 1.05	1.61 units on a scale Standard Deviation 1.04	1.66 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Induration(Upper limbs)(n=347,348,74,76)	1.13 units on a scale Standard Deviation 0.99	1.37 units on a scale Standard Deviation 1.02	2.09 units on a scale Standard Deviation 0.94	2.21 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Induration(Trunk)(n=347,348,74,76)	0.96 units on a scale Standard Deviation 1.02	1.30 units on a scale Standard Deviation 1.11	2.11 units on a scale Standard Deviation 1.08	2.21 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Induration(Lower limbs)(n=347,348,74,76)	1.12 units on a scale Standard Deviation 1.04	1.50 units on a scale Standard Deviation 1.11	2.36 units on a scale Standard Deviation 0.97	2.42 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Scaling(Head\Neck)(n=347,348,74,76)	0.74 units on a scale Standard Deviation 1.01	0.99 units on a scale Standard Deviation 1.10	1.77 units on a scale Standard Deviation 1.10	1.78 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Scaling(Upper limbs)(n=347,348,74,76)	1.11 units on a scale Standard Deviation 1.01	1.38 units on a scale Standard Deviation 1.09	2.04 units on a scale Standard Deviation 1.01	2.09 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Scaling(Trunk)(n=347,348,74,76)	0.88 units on a scale Standard Deviation 1.01	1.22 units on a scale Standard Deviation 1.12	1.97 units on a scale Standard Deviation 1.15	2.11 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 12:Scaling(Lower limbs)(n=347,348,74,76)	1.07 units on a scale Standard Deviation 1.05	1.50 units on a scale Standard Deviation 1.16	2.30 units on a scale Standard Deviation 1.03	2.30 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Erythema(Head\Neck)(n=340,345,74,76)	0.74 units on a scale Standard Deviation 0.95	1.06 units on a scale Standard Deviation 1.08	1.91 units on a scale Standard Deviation 1.12	1.75 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Erythema(Upper limbs)(n=340,345,74,76)	1.08 units on a scale Standard Deviation 0.97	1.37 units on a scale Standard Deviation 1.04	2.09 units on a scale Standard Deviation 1.02	2.28 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Erythema(Lower limbs)(n=340,345,74,76)	1.17 units on a scale Standard Deviation 1.07	1.51 units on a scale Standard Deviation 1.13	2.42 units on a scale Standard Deviation 1.05	2.46 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Induration(Trunk)(n=340,345,74,76)	0.79 units on a scale Standard Deviation 1.02	1.16 units on a scale Standard Deviation 1.15	2.01 units on a scale Standard Deviation 1.19	2.11 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Induration(Lower limbs)(n=340,345,74,76)	1.01 units on a scale Standard Deviation 1.06	1.34 units on a scale Standard Deviation 1.14	2.31 units on a scale Standard Deviation 1.03	2.33 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Scaling(Head\Neck)(n=340,345,74,76)	0.68 units on a scale Standard Deviation 0.99	1.00 units on a scale Standard Deviation 1.15	1.74 units on a scale Standard Deviation 1.15	1.68 units on a scale Standard Deviation 1.16
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Scaling(Upper limbs)(n=340,345,74,76)	1.03 units on a scale Standard Deviation 1.06	1.31 units on a scale Standard Deviation 1.17	2.04 units on a scale Standard Deviation 1.15	2.11 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Scaling(Trunk)(n=340,345,74,76)	0.75 units on a scale Standard Deviation 1.00	1.08 units on a scale Standard Deviation 1.15	1.84 units on a scale Standard Deviation 1.19	1.95 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 16:Scaling(Lower limbs)(n=340,345,74,76)	1.00 units on a scale Standard Deviation 1.07	1.38 units on a scale Standard Deviation 1.17	2.16 units on a scale Standard Deviation 1.12	2.34 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Erythema(Head\Neck)(n=327,338,74,76)	0.68 units on a scale Standard Deviation 0.91	0.93 units on a scale Standard Deviation 1.00	1.34 units on a scale Standard Deviation 1.06	1.11 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Erythema(Upper limbs)(n=327,338,74,76)	0.98 units on a scale Standard Deviation 0.92	1.23 units on a scale Standard Deviation 1.01	1.59 units on a scale Standard Deviation 0.96	1.55 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Erythema(Trunk)(n=327,338,74,76)	0.81 units on a scale Standard Deviation 0.99	1.14 units on a scale Standard Deviation 1.11	1.59 units on a scale Standard Deviation 1.12	1.59 units on a scale Standard Deviation 0.98
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Erythema(Lower limbs)(n=327,338,74,76)	1.02 units on a scale Standard Deviation 1.05	1.34 units on a scale Standard Deviation 1.05	1.82 units on a scale Standard Deviation 1.16	1.78 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Induration(Head\Neck)(n=327,338,74,76)	0.48 units on a scale Standard Deviation 0.76	0.77 units on a scale Standard Deviation 0.93	1.11 units on a scale Standard Deviation 0.92	0.89 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Induration(Upper limbs)(n=327,338,74,76)	0.96 units on a scale Standard Deviation 1.00	1.14 units on a scale Standard Deviation 1.06	1.43 units on a scale Standard Deviation 0.92	1.37 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Induration(Trunk)(n=327,338,74,76)	0.71 units on a scale Standard Deviation 0.96	0.98 units on a scale Standard Deviation 1.08	1.41 units on a scale Standard Deviation 1.06	1.26 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Induration(Lower limbs)(n=327,338,74,76)	0.87 units on a scale Standard Deviation 1.00	1.20 units on a scale Standard Deviation 1.06	1.68 units on a scale Standard Deviation 0.99	1.46 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Scaling(Head\Neck)(n=327,338,74,76)	0.63 units on a scale Standard Deviation 0.96	0.84 units on a scale Standard Deviation 1.01	1.11 units on a scale Standard Deviation 0.99	1.03 units on a scale Standard Deviation 1.06
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Scaling(Upper limbs)(n=327,338,74,76)	1.00 units on a scale Standard Deviation 1.05	1.14 units on a scale Standard Deviation 1.07	1.41 units on a scale Standard Deviation 1.05	1.37 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Scaling(Trunk)(n=327,338,74,76)	0.66 units on a scale Standard Deviation 0.93	0.89 units on a scale Standard Deviation 1.06	1.31 units on a scale Standard Deviation 1.08	1.21 units on a scale Standard Deviation 1.02
Psoriasis Area and Severity Index (PASI) Component Scores Week 20:Scaling(Lower limbs)(n=327,338,74,76)	0.89 units on a scale Standard Deviation 1.08	1.17 units on a scale Standard Deviation 1.10	1.43 units on a scale Standard Deviation 0.99	1.50 units on a scale Standard Deviation 1.09
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Erythema(Head\Neck)(n=305,327,69,72)	0.65 units on a scale Standard Deviation 0.93	0.88 units on a scale Standard Deviation 0.95	0.90 units on a scale Standard Deviation 1.06	0.76 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Erythema(Upper limbs)(n=305,327,69,72)	0.96 units on a scale Standard Deviation 0.98	1.17 units on a scale Standard Deviation 0.97	1.26 units on a scale Standard Deviation 1.01	1.15 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Erythema(Trunk)(n=305,327,69,72)	0.81 units on a scale Standard Deviation 1.06	1.00 units on a scale Standard Deviation 1.07	1.09 units on a scale Standard Deviation 1.20	0.88 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Erythema(Lower limbs)(n=305,327,69,72)	0.96 units on a scale Standard Deviation 1.11	1.20 units on a scale Standard Deviation 1.02	1.39 units on a scale Standard Deviation 1.05	0.99 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Induration(Head\Neck)(n=305,327,69,72)	0.47 units on a scale Standard Deviation 0.75	0.71 units on a scale Standard Deviation 0.90	0.78 units on a scale Standard Deviation 0.97	0.60 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Induration(Upper limbs)(n=305,327,69,72)	0.95 units on a scale Standard Deviation 1.02	1.10 units on a scale Standard Deviation 1.05	1.10 units on a scale Standard Deviation 0.93	0.94 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Induration(Trunk)(n=305,327,69,72)	0.67 units on a scale Standard Deviation 0.94	0.90 units on a scale Standard Deviation 1.04	0.94 units on a scale Standard Deviation 1.08	0.76 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Induration(Lower limbs)(n=305,327,69,72)	0.80 units on a scale Standard Deviation 1.04	1.08 units on a scale Standard Deviation 1.04	1.29 units on a scale Standard Deviation 1.03	0.89 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Scaling(Head\Neck)(n=305,327,69,72)	0.60 units on a scale Standard Deviation 0.92	0.81 units on a scale Standard Deviation 0.97	0.80 units on a scale Standard Deviation 1.02	0.68 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Scaling(Upper limbs)(n=305,327,69,72)	0.96 units on a scale Standard Deviation 1.08	1.07 units on a scale Standard Deviation 1.07	1.20 units on a scale Standard Deviation 1.04	1.10 units on a scale Standard Deviation 1.02
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Scaling(Trunk)(n=305,327,69,72)	0.63 units on a scale Standard Deviation 0.96	0.81 units on a scale Standard Deviation 1.00	0.96 units on a scale Standard Deviation 1.17	0.79 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 28:Scaling(Lower limbs)(n=305,327,69,72)	0.84 units on a scale Standard Deviation 1.11	1.05 units on a scale Standard Deviation 1.07	1.22 units on a scale Standard Deviation 1.04	0.90 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Erythema(Head\Neck)(n=213,263,46,55)	0.48 units on a scale Standard Deviation 0.75	0.67 units on a scale Standard Deviation 0.85	0.72 units on a scale Standard Deviation 1.07	0.51 units on a scale Standard Deviation 0.72
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Erythema(Upper limbs)(n=213,263,46,55)	0.76 units on a scale Standard Deviation 0.85	0.85 units on a scale Standard Deviation 0.87	0.98 units on a scale Standard Deviation 1.00	0.78 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Erythema(Trunk)(n=213,263,46,55)	0.62 units on a scale Standard Deviation 0.95	0.65 units on a scale Standard Deviation 0.88	0.72 units on a scale Standard Deviation 0.98	0.45 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Erythema(Lower limbs)(n=213,263,46,55)	0.72 units on a scale Standard Deviation 0.94	0.82 units on a scale Standard Deviation 0.93	1.00 units on a scale Standard Deviation 1.03	0.69 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Induration(Head\Neck)(n=213,263,46,55)	0.36 units on a scale Standard Deviation 0.64	0.48 units on a scale Standard Deviation 0.76	0.54 units on a scale Standard Deviation 0.91	0.38 units on a scale Standard Deviation 0.73
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Induration(Upper limbs)(n=213,263,46,55)	0.73 units on a scale Standard Deviation 0.92	0.78 units on a scale Standard Deviation 0.91	0.89 units on a scale Standard Deviation 1.04	0.85 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Induration(Trunk)(n=213,263,46,55)	0.51 units on a scale Standard Deviation 0.89	0.52 units on a scale Standard Deviation 0.82	0.57 units on a scale Standard Deviation 0.93	0.45 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Induration(Lower limbs)(n=213,263,46,55)	0.62 units on a scale Standard Deviation 0.91	0.70 units on a scale Standard Deviation 0.89	0.85 units on a scale Standard Deviation 0.99	0.62 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Scaling(Head\Neck)(n=213,263,46,55)	0.46 units on a scale Standard Deviation 0.81	0.67 units on a scale Standard Deviation 0.95	0.67 units on a scale Standard Deviation 1.01	0.58 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Scaling(Upper limbs)(n=213,263,46,55)	0.74 units on a scale Standard Deviation 0.96	0.84 units on a scale Standard Deviation 1.03	0.89 units on a scale Standard Deviation 1.06	0.89 units on a scale Standard Deviation 1.03
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Scaling(Trunk)(n=213,263,46,55)	0.47 units on a scale Standard Deviation 0.84	0.56 units on a scale Standard Deviation 0.91	0.57 units on a scale Standard Deviation 0.98	0.47 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores Week 40:Scaling(Lower limbs)(n=213,263,46,55)	0.63 units on a scale Standard Deviation 0.96	0.74 units on a scale Standard Deviation 0.95	0.93 units on a scale Standard Deviation 1.12	0.71 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Erythema(Head\Neck)(n=194,239,38,42)	0.48 units on a scale Standard Deviation 0.77	0.70 units on a scale Standard Deviation 0.90	0.68 units on a scale Standard Deviation 0.96	0.48 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Erythema(Upper limbs)(n=194,239,38,42)	0.77 units on a scale Standard Deviation 0.88	0.91 units on a scale Standard Deviation 0.93	1.05 units on a scale Standard Deviation 0.93	0.88 units on a scale Standard Deviation 1.04
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Erythema(Trunk)(n=194,239,38,42)	0.60 units on a scale Standard Deviation 0.91	0.74 units on a scale Standard Deviation 1.01	0.76 units on a scale Standard Deviation 0.88	0.48 units on a scale Standard Deviation 0.71
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Erythema(Lower limbs)(n=194,239,38,42)	0.76 units on a scale Standard Deviation 0.97	0.87 units on a scale Standard Deviation 1.01	0.84 units on a scale Standard Deviation 1.03	0.79 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Induration(Head\Neck)(n=194,239,38,42)	0.33 units on a scale Standard Deviation 0.60	0.49 units on a scale Standard Deviation 0.76	0.53 units on a scale Standard Deviation 0.80	0.33 units on a scale Standard Deviation 0.65
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Induration(Upper limbs)(n=194,239,38,42)	0.69 units on a scale Standard Deviation 0.87	0.79 units on a scale Standard Deviation 0.93	0.95 units on a scale Standard Deviation 0.93	0.76 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Induration(Trunk)(n=194,239,38,42)	0.46 units on a scale Standard Deviation 0.74	0.55 units on a scale Standard Deviation 0.85	0.61 units on a scale Standard Deviation 0.82	0.50 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Induration(Lower limbs)(n=194,239,38,42)	0.64 units on a scale Standard Deviation 0.89	0.69 units on a scale Standard Deviation 0.92	0.76 units on a scale Standard Deviation 0.97	0.69 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Scaling(Head\Neck)(n=194,239,38,42)	0.45 units on a scale Standard Deviation 0.78	0.63 units on a scale Standard Deviation 0.87	0.58 units on a scale Standard Deviation 0.83	0.43 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Scaling(Upper limbs)(n=194,239,38,42)	0.70 units on a scale Standard Deviation 0.92	0.84 units on a scale Standard Deviation 0.97	0.95 units on a scale Standard Deviation 0.93	0.81 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Scaling(Trunk)(n=194,239,38,42)	0.45 units on a scale Standard Deviation 0.75	0.58 units on a scale Standard Deviation 0.88	0.66 units on a scale Standard Deviation 0.94	0.45 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 52:Scaling(Lower limbs)(n=194,239,38,42)	0.64 units on a scale Standard Deviation 0.92	0.72 units on a scale Standard Deviation 0.95	0.89 units on a scale Standard Deviation 1.13	0.74 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Erythema(Head\Neck)(n=376,374,74,76)	2.30 units on a scale Standard Deviation 1.04	2.35 units on a scale Standard Deviation 0.97	2.36 units on a scale Standard Deviation 0.92	2.29 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Erythema(Upper limbs)(n=376,374,74,76)	2.90 units on a scale Standard Deviation 0.61	2.89 units on a scale Standard Deviation 0.66	2.82 units on a scale Standard Deviation 0.65	2.86 units on a scale Standard Deviation 0.71
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Erythema(Trunk)(n=376,374,74,76)	2.93 units on a scale Standard Deviation 0.70	2.92 units on a scale Standard Deviation 0.70	2.96 units on a scale Standard Deviation 0.71	2.80 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Erythema(Lower limbs)(n=376,374,74,76)	3.18 units on a scale Standard Deviation 0.60	3.18 units on a scale Standard Deviation 0.63	3.16 units on a scale Standard Deviation 0.50	3.17 units on a scale Standard Deviation 0.64
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration(Head\Neck)(n=376,374,74,76)	2.02 units on a scale Standard Deviation 1.03	2.11 units on a scale Standard Deviation 1.05	2.24 units on a scale Standard Deviation 0.90	2.00 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration(Upper limbs)(n=376,374,74,76)	2.74 units on a scale Standard Deviation 0.70	2.79 units on a scale Standard Deviation 0.69	2.66 units on a scale Standard Deviation 0.63	2.86 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration(Trunk)(n=376,374,74,76)	2.72 units on a scale Standard Deviation 0.77	2.69 units on a scale Standard Deviation 0.76	2.69 units on a scale Standard Deviation 0.68	2.64 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration(Lower limbs)(n=376,374,74,76)	2.99 units on a scale Standard Deviation 0.70	2.95 units on a scale Standard Deviation 0.69	2.86 units on a scale Standard Deviation 0.63	2.92 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Scaling(Head\Neck)(n=376,374,74,76)	2.32 units on a scale Standard Deviation 1.10	2.33 units on a scale Standard Deviation 1.09	2.47 units on a scale Standard Deviation 1.05	2.30 units on a scale Standard Deviation 1.03
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Scaling(Upper limbs)(n=376,374,74,76)	2.77 units on a scale Standard Deviation 0.73	2.77 units on a scale Standard Deviation 0.73	2.78 units on a scale Standard Deviation 0.73	2.79 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Scaling(Trunk)(n=376,374,74,76)	2.68 units on a scale Standard Deviation 0.77	2.69 units on a scale Standard Deviation 0.77	2.77 units on a scale Standard Deviation 0.79	2.61 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Scaling(Lower limbs)(n=376,374,74,76)	3.04 units on a scale Standard Deviation 0.66	3.02 units on a scale Standard Deviation 0.74	3.03 units on a scale Standard Deviation 0.62	3.03 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Erythema(Head\Neck)(n=369,367,73,76)	1.76 units on a scale Standard Deviation 1.07	1.86 units on a scale Standard Deviation 1.05	2.30 units on a scale Standard Deviation 0.89	2.07 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Erythema(Upper limbs)(n=369,367,73,76)	2.27 units on a scale Standard Deviation 0.82	2.41 units on a scale Standard Deviation 0.82	2.70 units on a scale Standard Deviation 0.74	2.57 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Erythema(Trunk)(n=369,367,73,76)	2.35 units on a scale Standard Deviation 0.89	2.45 units on a scale Standard Deviation 0.85	2.82 units on a scale Standard Deviation 0.73	2.55 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Erythema(Lower limbs)(n=369,367,73,76)	2.63 units on a scale Standard Deviation 0.83	2.78 units on a scale Standard Deviation 0.81	3.07 units on a scale Standard Deviation 0.51	2.91 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Induration(Head\Neck)(n=369,367,73,76)	1.53 units on a scale Standard Deviation 1.07	1.73 units on a scale Standard Deviation 1.10	2.11 units on a scale Standard Deviation 0.86	1.86 units on a scale Standard Deviation 0.96
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Induration(Upper limbs)(n=369,367,73,76)	2.20 units on a scale Standard Deviation 0.85	2.36 units on a scale Standard Deviation 0.82	2.53 units on a scale Standard Deviation 0.71	2.53 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Induration(Trunk)(n=369,367,73,76)	2.22 units on a scale Standard Deviation 0.91	2.33 units on a scale Standard Deviation 0.87	2.52 units on a scale Standard Deviation 0.71	2.38 units on a scale Standard Deviation 0.92
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Induration(Lower limbs)(n=369,367,73,76)	2.48 units on a scale Standard Deviation 0.83	2.60 units on a scale Standard Deviation 0.81	2.73 units on a scale Standard Deviation 0.71	2.66 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Scaling(Head\Neck)(n=369,367,73,76)	1.69 units on a scale Standard Deviation 1.15	1.80 units on a scale Standard Deviation 1.19	2.33 units on a scale Standard Deviation 1.04	2.11 units on a scale Standard Deviation 1.03
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Scaling(Upper limbs)(n=369,367,73,76)	2.16 units on a scale Standard Deviation 0.92	2.25 units on a scale Standard Deviation 0.92	2.56 units on a scale Standard Deviation 0.90	2.36 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Week 2:Scaling(Lower limbs)(n=369,367,73,76)	2.48 units on a scale Standard Deviation 0.90	2.53 units on a scale Standard Deviation 0.91	2.71 units on a scale Standard Deviation 0.84	2.67 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Erythema(Head\Neck)(n=363,366,74,75)	1.31 units on a scale Standard Deviation 1.09	1.49 units on a scale Standard Deviation 1.04	2.11 units on a scale Standard Deviation 0.90	2.05 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Erythema(Upper limbs)(n=363,366,74,75)	1.82 units on a scale Standard Deviation 0.89	2.00 units on a scale Standard Deviation 0.86	2.53 units on a scale Standard Deviation 0.81	2.53 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Erythema(Trunk)(n=363,366,74,75)	1.89 units on a scale Standard Deviation 0.95	2.07 units on a scale Standard Deviation 0.93	2.50 units on a scale Standard Deviation 0.95	2.49 units on a scale Standard Deviation 0.92
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Erythema(Lower limbs)(n=363,366,74,75)	2.11 units on a scale Standard Deviation 0.90	2.34 units on a scale Standard Deviation 0.90	2.74 units on a scale Standard Deviation 0.76	2.80 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Induration(Head\Neck)(n=363,366,74,75)	1.08 units on a scale Standard Deviation 1.00	1.30 units on a scale Standard Deviation 1.05	1.86 units on a scale Standard Deviation 0.91	1.72 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Induration(Upper limbs)(n=363,366,74,75)	1.67 units on a scale Standard Deviation 0.91	1.91 units on a scale Standard Deviation 0.86	2.41 units on a scale Standard Deviation 0.77	2.40 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Induration(Trunk)(n=363,366,74,75)	1.72 units on a scale Standard Deviation 0.99	1.89 units on a scale Standard Deviation 0.94	2.27 units on a scale Standard Deviation 0.91	2.36 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Induration(Lower limbs)(n=363,366,74,75)	1.93 units on a scale Standard Deviation 0.95	2.16 units on a scale Standard Deviation 0.93	2.55 units on a scale Standard Deviation 0.80	2.51 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores Week 4:Scaling(Head\Neck)(n=363,366,74,75)	1.20 units on a scale Standard Deviation 1.11	1.42 units on a scale Standard Deviation 1.16	2.00 units on a scale Standard Deviation 1.07	1.95 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Erythema(Lower limbs)(n=194,239,38,42)	-2.32 units on a scale Standard Deviation 1.12	-2.44 units on a scale Standard Deviation 1.09	-2.39 units on a scale Standard Deviation 1.17	-2.52 units on a scale Standard Deviation 1.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Induration(Head\Neck)(n=363,366,74,75)	-0.81 units on a scale Standard Deviation 0.96	-0.97 units on a scale Standard Deviation 0.97	-0.38 units on a scale Standard Deviation 0.81	-0.29 units on a scale Standard Deviation 0.71
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Induration(Head\Neck)(n=354,356,74,76)	-1.05 units on a scale Standard Deviation 1.12	-1.27 units on a scale Standard Deviation 1.10	-0.62 units on a scale Standard Deviation 1.02	-0.36 units on a scale Standard Deviation 0.87
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Induration(Head\Neck)(n=347,348,74,76)	-1.18 units on a scale Standard Deviation 1.21	-1.42 units on a scale Standard Deviation 1.15	-0.64 units on a scale Standard Deviation 1.07	-0.34 units on a scale Standard Deviation 0.93
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Induration(Head\Neck)(n=305,327,69,72)	-1.41 units on a scale Standard Deviation 1.14	-1.55 units on a scale Standard Deviation 1.14	-1.41 units on a scale Standard Deviation 1.15	-1.44 units on a scale Standard Deviation 1.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Induration(Head\Neck)(n=213,263,46,55)	-1.67 units on a scale Standard Deviation 1.12	-1.66 units on a scale Standard Deviation 1.15	-1.78 units on a scale Standard Deviation 1.11	-1.73 units on a scale Standard Deviation 1.03
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Induration(Upper limbs)(n=369,367,73,76)	-0.42 units on a scale Standard Deviation 0.65	-0.54 units on a scale Standard Deviation 0.70	-0.12 units on a scale Standard Deviation 0.47	-0.33 units on a scale Standard Deviation 0.62
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Induration(Upper limbs)(n=363,366,74,75)	-0.87 units on a scale Standard Deviation 0.85	-1.07 units on a scale Standard Deviation 0.93	-0.26 units on a scale Standard Deviation 0.74	-0.44 units on a scale Standard Deviation 0.66
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Induration(Trunk)(n=347,348,74,76)	-1.40 units on a scale Standard Deviation 1.20	-1.79 units on a scale Standard Deviation 1.17	-0.58 units on a scale Standard Deviation 1.16	-0.43 units on a scale Standard Deviation 1.04
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Induration(Trunk)(n=327,338,74,76)	-1.72 units on a scale Standard Deviation 1.28	-2.04 units on a scale Standard Deviation 1.14	-1.28 units on a scale Standard Deviation 1.21	-1.38 units on a scale Standard Deviation 1.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Induration(Trunk)(n=305,327,69,72)	-1.83 units on a scale Standard Deviation 1.21	-2.07 units on a scale Standard Deviation 1.16	-1.74 units on a scale Standard Deviation 1.29	-1.94 units on a scale Standard Deviation 1.28
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Induration(Trunk)(n=194,239,38,42)	-2.17 units on a scale Standard Deviation 1.15	-2.32 units on a scale Standard Deviation 1.03	-2.18 units on a scale Standard Deviation 1.14	-2.24 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Induration(Lower limbs)(n=327,338,74,76)	-1.76 units on a scale Standard Deviation 1.23	-2.12 units on a scale Standard Deviation 1.21	-1.19 units on a scale Standard Deviation 1.24	-1.46 units on a scale Standard Deviation 1.00
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Induration(Lower limbs)(n=305,327,69,72)	-1.87 units on a scale Standard Deviation 1.22	-2.19 units on a scale Standard Deviation 1.27	-1.58 units on a scale Standard Deviation 1.39	-2.07 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Scaling(Head\Neck)(n=354,356,74,76)	-1.20 units on a scale Standard Deviation 1.17	-1.44 units on a scale Standard Deviation 1.18	-0.65 units on a scale Standard Deviation 1.05	-0.51 units on a scale Standard Deviation 0.96
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Scaling(Upper limbs)(n=369,367,73,76)	-0.51 units on a scale Standard Deviation 0.79	-0.60 units on a scale Standard Deviation 0.73	-0.22 units on a scale Standard Deviation 0.58	-0.43 units on a scale Standard Deviation 0.62
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Scaling(Upper limbs)(n=354,356,74,76)	-1.23 units on a scale Standard Deviation 1.07	-1.47 units on a scale Standard Deviation 1.13	-0.61 units on a scale Standard Deviation 0.90	-0.59 units on a scale Standard Deviation 0.88
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Scaling(Upper limbs)(n=347,348,74,76)	-1.39 units on a scale Standard Deviation 1.19	-1.65 units on a scale Standard Deviation 1.18	-0.74 units on a scale Standard Deviation 1.02	-0.70 units on a scale Standard Deviation 0.91
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Scaling(Upper limbs)(n=340,345,74,76)	-1.47 units on a scale Standard Deviation 1.26	-1.73 units on a scale Standard Deviation 1.24	-0.74 units on a scale Standard Deviation 1.23	-0.68 units on a scale Standard Deviation 1.00
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Scaling(Upper limbs)(n=327,338,74,76)	-1.63 units on a scale Standard Deviation 1.19	-1.76 units on a scale Standard Deviation 1.23	-1.38 units on a scale Standard Deviation 1.18	-1.42 units on a scale Standard Deviation 1.00
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Scaling(Upper limbs)(n=305,327,69,72)	-1.69 units on a scale Standard Deviation 1.22	-1.82 units on a scale Standard Deviation 1.30	-1.57 units on a scale Standard Deviation 1.25	-1.71 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Scaling(Lower limbs)(n=363,366,74,75)	-0.88 units on a scale Standard Deviation 0.97	-1.10 units on a scale Standard Deviation 1.01	-0.46 units on a scale Standard Deviation 0.83	-0.56 units on a scale Standard Deviation 0.84
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Erythema(Head\Neck)(n=369,367,73,76)	-0.48 units on a scale Standard Deviation 0.76	-0.56 units on a scale Standard Deviation 0.77	-0.05 units on a scale Standard Deviation 0.50	-0.22 units on a scale Standard Deviation 0.53
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Erythema(Head\Neck)(n=363,366,74,75)	-0.85 units on a scale Standard Deviation 0.97	-1.01 units on a scale Standard Deviation 1.04	-0.26 units on a scale Standard Deviation 0.70	-0.25 units on a scale Standard Deviation 0.70
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Erythema(Head\Neck)(n=354,356,74,76)	-1.09 units on a scale Standard Deviation 1.07	-1.35 units on a scale Standard Deviation 1.12	-0.51 units on a scale Standard Deviation 0.95	-0.50 units on a scale Standard Deviation 0.82
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Erythema(Head\Neck)(n=347,348,74,76)	-1.25 units on a scale Standard Deviation 1.17	-1.54 units on a scale Standard Deviation 1.16	-0.50 units on a scale Standard Deviation 1.01	-0.36 units on a scale Standard Deviation 0.89
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Erythema(Head\Neck)(n=340,345,74,76)	-1.27 units on a scale Standard Deviation 1.17	-1.57 units on a scale Standard Deviation 1.17	-0.46 units on a scale Standard Deviation 1.15	-0.54 units on a scale Standard Deviation 0.90
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Erythema(Head\Neck)(n=327,338,74,76)	-1.39 units on a scale Standard Deviation 1.16	-1.62 units on a scale Standard Deviation 1.17	-1.03 units on a scale Standard Deviation 1.06	-1.18 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Erythema(Head\Neck)(n=305,327,69,72)	-1.46 units on a scale Standard Deviation 1.10	-1.64 units on a scale Standard Deviation 1.18	-1.42 units on a scale Standard Deviation 1.14	-1.56 units on a scale Standard Deviation 1.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Erythema(Head\Neck)(n=213,263,46,55)	-1.69 units on a scale Standard Deviation 1.05	-1.79 units on a scale Standard Deviation 1.14	-1.67 units on a scale Standard Deviation 1.21	-1.78 units on a scale Standard Deviation 0.96
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Erythema(Head\Neck)(n=194,239,38,42)	-1.64 units on a scale Standard Deviation 1.06	-1.82 units on a scale Standard Deviation 1.11	-1.66 units on a scale Standard Deviation 1.19	-1.95 units on a scale Standard Deviation 1.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Erythema(Upper limbs)(n=369,367,73,76)	-0.48 units on a scale Standard Deviation 0.71	-0.63 units on a scale Standard Deviation 0.68	-0.12 units on a scale Standard Deviation 0.47	-0.29 units on a scale Standard Deviation 0.63
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Erythema(Upper limbs)(n=363,366,74,75)	-0.89 units on a scale Standard Deviation 0.86	-1.08 units on a scale Standard Deviation 0.90	-0.30 units on a scale Standard Deviation 0.70	-0.32 units on a scale Standard Deviation 0.70
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Erythema(Upper limbs)(n=354,356,74,76)	-1.18 units on a scale Standard Deviation 0.98	-1.51 units on a scale Standard Deviation 1.01	-0.54 units on a scale Standard Deviation 0.88	-0.38 units on a scale Standard Deviation 0.80
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Erythema(Trunk)(n=340,345,74,76)	-1.58 units on a scale Standard Deviation 1.25	-1.99 units on a scale Standard Deviation 1.17	-0.88 units on a scale Standard Deviation 1.17	-0.50 units on a scale Standard Deviation 1.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Erythema(Trunk)(n=327,338,74,76)	-1.80 units on a scale Standard Deviation 1.25	-2.12 units on a scale Standard Deviation 1.12	-1.36 units on a scale Standard Deviation 1.18	-1.21 units on a scale Standard Deviation 1.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Erythema(Upper limbs)(n=347,348,74,76)	-1.40 units on a scale Standard Deviation 1.08	-1.71 units on a scale Standard Deviation 1.05	-0.65 units on a scale Standard Deviation 1.05	-0.57 units on a scale Standard Deviation 0.88
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Erythema(Trunk)(n=305,327,69,72)	-1.94 units on a scale Standard Deviation 1.20	-2.12 units on a scale Standard Deviation 1.17	-1.88 units on a scale Standard Deviation 1.28	-1.94 units on a scale Standard Deviation 1.32
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Erythema(Trunk)(n=213,263,46,55)	-2.26 units on a scale Standard Deviation 1.04	-2.31 units on a scale Standard Deviation 1.12	-2.28 units on a scale Standard Deviation 1.11	-2.45 units on a scale Standard Deviation 1.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Erythema(Trunk)(n=194,239,38,42)	-2.19 units on a scale Standard Deviation 1.13	-2.36 units on a scale Standard Deviation 1.03	-2.29 units on a scale Standard Deviation 1.18	-2.48 units on a scale Standard Deviation 1.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Erythema(Lower limbs)(n=327,338,74,76)	-1.84 units on a scale Standard Deviation 1.18	-2.15 units on a scale Standard Deviation 1.16	-1.34 units on a scale Standard Deviation 1.20	-1.39 units on a scale Standard Deviation 1.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Induration(Lower limbs)(n=340,345,74,76)	-1.63 units on a scale Standard Deviation 1.26	-1.97 units on a scale Standard Deviation 1.25	-0.55 units on a scale Standard Deviation 1.21	-0.59 units on a scale Standard Deviation 0.98
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Erythema(Lower limbs)(n=369,367,73,76)	-0.40 units on a scale Standard Deviation 0.66	-0.55 units on a scale Standard Deviation 0.68	-0.10 units on a scale Standard Deviation 0.48	-0.26 units on a scale Standard Deviation 0.62
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Erythema(Upper limbs)(n=340,345,74,76)	-1.53 units on a scale Standard Deviation 1.16	-1.81 units on a scale Standard Deviation 1.13	-0.73 units on a scale Standard Deviation 1.19	-0.58 units on a scale Standard Deviation 0.93
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Erythema(Upper limbs)(n=327,338,74,76)	-1.66 units on a scale Standard Deviation 1.17	-1.91 units on a scale Standard Deviation 1.11	-1.23 units on a scale Standard Deviation 1.15	-1.30 units on a scale Standard Deviation 1.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Erythema(Upper limbs)(n=305,327,69,72)	-1.72 units on a scale Standard Deviation 1.13	-1.92 units on a scale Standard Deviation 1.16	-1.57 units on a scale Standard Deviation 1.23	-1.72 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Erythema(Lower limbs)(n=363,366,74,75)	-0.84 units on a scale Standard Deviation 0.85	-1.07 units on a scale Standard Deviation 0.87	-0.42 units on a scale Standard Deviation 0.72	-0.36 units on a scale Standard Deviation 0.80
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Scaling(Head\Neck)(n=347,348,74,76)	-1.37 units on a scale Standard Deviation 1.25	-1.60 units on a scale Standard Deviation 1.22	-0.70 units on a scale Standard Deviation 1.07	-0.53 units on a scale Standard Deviation 1.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Erythema(Lower limbs)(n=354,356,74,76)	-1.25 units on a scale Standard Deviation 1.05	-1.57 units on a scale Standard Deviation 1.04	-0.61 units on a scale Standard Deviation 0.89	-0.45 units on a scale Standard Deviation 0.87
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Erythema(Lower limbs)(n=347,348,74,76)	-1.46 units on a scale Standard Deviation 1.12	-1.85 units on a scale Standard Deviation 1.12	-0.66 units on a scale Standard Deviation 0.95	-0.57 units on a scale Standard Deviation 1.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Erythema(Lower limbs)(n=340,345,74,76)	-1.68 units on a scale Standard Deviation 1.20	-2.00 units on a scale Standard Deviation 1.18	-0.74 units on a scale Standard Deviation 1.07	-0.71 units on a scale Standard Deviation 1.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Erythema(Lower limbs)(n=305,327,69,72)	-1.98 units on a scale Standard Deviation 1.18	-2.21 units on a scale Standard Deviation 1.22	-1.80 units on a scale Standard Deviation 1.18	-2.19 units on a scale Standard Deviation 1.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Erythema(Lower limbs)(n=213,263,46,55)	-2.38 units on a scale Standard Deviation 1.05	-2.46 units on a scale Standard Deviation 1.08	-2.17 units on a scale Standard Deviation 1.18	-2.55 units on a scale Standard Deviation 1.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Induration(Head\Neck)(n=369,367,73,76)	-0.36 units on a scale Standard Deviation 0.72	-0.51 units on a scale Standard Deviation 0.76	-0.12 units on a scale Standard Deviation 0.55	-0.14 units on a scale Standard Deviation 0.51
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Induration(Head\Neck)(n=340,345,74,76)	-1.20 units on a scale Standard Deviation 1.20	-1.45 units on a scale Standard Deviation 1.17	-0.58 units on a scale Standard Deviation 1.09	-0.47 units on a scale Standard Deviation 0.97
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Induration(Head\Neck)(n=327,338,74,76)	-1.33 units on a scale Standard Deviation 1.17	-1.54 units on a scale Standard Deviation 1.13	-1.14 units on a scale Standard Deviation 1.00	-1.11 units on a scale Standard Deviation 1.04
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Erythema(Upper limbs)(n=213,263,46,55)	-2.05 units on a scale Standard Deviation 1.04	-2.15 units on a scale Standard Deviation 1.00	-1.96 units on a scale Standard Deviation 1.07	-2.11 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Erythema(Upper limbs)(n=194,239,38,42)	-1.99 units on a scale Standard Deviation 1.07	-2.15 units on a scale Standard Deviation 1.04	-1.92 units on a scale Standard Deviation 1.08	-2.07 units on a scale Standard Deviation 1.28
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Erythema(Trunk)(n=369,367,73,76)	-0.47 units on a scale Standard Deviation 0.69	-0.59 units on a scale Standard Deviation 0.70	-0.14 units on a scale Standard Deviation 0.58	-0.25 units on a scale Standard Deviation 0.66
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Erythema(Trunk)(n=363,366,74,75)	-0.86 units on a scale Standard Deviation 0.90	-1.04 units on a scale Standard Deviation 0.90	-0.46 units on a scale Standard Deviation 0.91	-0.31 units on a scale Standard Deviation 0.88
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Erythema(Trunk)(n=354,356,74,76)	-1.18 units on a scale Standard Deviation 1.09	-1.56 units on a scale Standard Deviation 1.07	-0.69 units on a scale Standard Deviation 1.05	-0.34 units on a scale Standard Deviation 1.01
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Erythema(Trunk)(n=347,348,74,76)	-1.41 units on a scale Standard Deviation 1.19	-1.82 units on a scale Standard Deviation 1.10	-0.72 units on a scale Standard Deviation 1.08	-0.42 units on a scale Standard Deviation 1.02
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Induration(Trunk)(n=213,263,46,55)	-2.20 units on a scale Standard Deviation 1.09	-2.25 units on a scale Standard Deviation 1.13	-2.22 units on a scale Standard Deviation 1.15	-2.29 units on a scale Standard Deviation 1.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Induration(Lower limbs)(n=369,367,73,76)	-0.35 units on a scale Standard Deviation 0.65	-0.51 units on a scale Standard Deviation 0.70	-0.14 units on a scale Standard Deviation 0.54	-0.26 units on a scale Standard Deviation 0.53
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Induration(Lower limbs)(n=363,366,74,75)	-0.80 units on a scale Standard Deviation 0.88	-1.06 units on a scale Standard Deviation 0.96	-0.31 units on a scale Standard Deviation 0.76	-0.40 units on a scale Standard Deviation 0.75
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Induration(Lower limbs)(n=354,356,74,76)	-1.23 units on a scale Standard Deviation 1.09	-1.59 units on a scale Standard Deviation 1.15	-0.45 units on a scale Standard Deviation 0.98	-0.41 units on a scale Standard Deviation 0.73
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Induration(Lower limbs)(n=347,348,74,76)	-1.46 units on a scale Standard Deviation 1.17	-1.86 units on a scale Standard Deviation 1.20	-0.50 units on a scale Standard Deviation 1.10	-0.50 units on a scale Standard Deviation 0.95
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Induration(Lower limbs)(n=213,263,46,55)	-2.31 units on a scale Standard Deviation 1.10	-2.43 units on a scale Standard Deviation 1.09	-2.15 units on a scale Standard Deviation 1.23	-2.40 units on a scale Standard Deviation 0.97
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Induration(Lower limbs)(n=194,239,38,42)	-2.30 units on a scale Standard Deviation 1.17	-2.40 units on a scale Standard Deviation 1.08	-2.26 units on a scale Standard Deviation 1.25	-2.29 units on a scale Standard Deviation 1.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Scaling(Head\Neck)(n=369,367,73,76)	-0.53 units on a scale Standard Deviation 0.86	-0.65 units on a scale Standard Deviation 0.83	-0.14 units on a scale Standard Deviation 0.61	-0.20 units on a scale Standard Deviation 0.63
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Scaling(Head\Neck)(n=363,366,74,75)	-0.92 units on a scale Standard Deviation 1.07	-1.13 units on a scale Standard Deviation 1.05	-0.47 units on a scale Standard Deviation 0.95	-0.36 units on a scale Standard Deviation 0.82
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Scaling(Head\Neck)(n=340,345,74,76)	-1.34 units on a scale Standard Deviation 1.29	-1.66 units on a scale Standard Deviation 1.22	-0.73 units on a scale Standard Deviation 1.24	-0.62 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Scaling(Head\Neck)(n=327,338,74,76)	-1.49 units on a scale Standard Deviation 1.21	-1.69 units on a scale Standard Deviation 1.23	-1.36 units on a scale Standard Deviation 1.14	-1.28 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Scaling(Head\Neck)(n=305,327,69,72)	-1.54 units on a scale Standard Deviation 1.17	-1.70 units on a scale Standard Deviation 1.20	-1.62 units on a scale Standard Deviation 1.26	-1.64 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Scaling(Head\Neck)(n=213,263,46,55)	-1.70 units on a scale Standard Deviation 1.21	-1.83 units on a scale Standard Deviation 1.20	-1.93 units on a scale Standard Deviation 1.32	-1.76 units on a scale Standard Deviation 1.29
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Induration(Trunk)(n=363,366,74,75)	-0.79 units on a scale Standard Deviation 0.89	-1.01 units on a scale Standard Deviation 0.94	-0.42 units on a scale Standard Deviation 0.91	-0.28 units on a scale Standard Deviation 0.81
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Scaling(Head\Neck)(n=194,239,38,42)	-1.71 units on a scale Standard Deviation 1.11	-1.86 units on a scale Standard Deviation 1.19	-2.00 units on a scale Standard Deviation 1.21	-2.00 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Scaling(Upper limbs)(n=363,366,74,75)	-0.92 units on a scale Standard Deviation 0.92	-1.12 units on a scale Standard Deviation 0.98	-0.47 units on a scale Standard Deviation 0.85	-0.52 units on a scale Standard Deviation 0.81
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Scaling(Upper limbs)(n=213,263,46,55)	-1.93 units on a scale Standard Deviation 1.25	-2.07 units on a scale Standard Deviation 1.18	-2.02 units on a scale Standard Deviation 1.24	-1.95 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Scaling(Upper limbs)(n=194,239,38,42)	-1.92 units on a scale Standard Deviation 1.21	-2.13 units on a scale Standard Deviation 1.14	-1.95 units on a scale Standard Deviation 1.16	-1.95 units on a scale Standard Deviation 1.27
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Scaling(Trunk)(n=369,367,73,76)	-0.50 units on a scale Standard Deviation 0.75	-0.57 units on a scale Standard Deviation 0.78	-0.33 units on a scale Standard Deviation 0.60	-0.32 units on a scale Standard Deviation 0.66
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 4:Scaling(Trunk)(n=363,366,74,75)	-0.85 units on a scale Standard Deviation 0.97	-1.08 units on a scale Standard Deviation 0.99	-0.54 units on a scale Standard Deviation 0.97	-0.43 units on a scale Standard Deviation 0.96
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Scaling(Trunk)(n=354,356,74,76)	-1.27 units on a scale Standard Deviation 1.15	-1.59 units on a scale Standard Deviation 1.17	-0.74 units on a scale Standard Deviation 1.11	-0.46 units on a scale Standard Deviation 0.99
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Scaling(Trunk)(n=347,348,74,76)	-1.48 units on a scale Standard Deviation 1.23	-1.81 units on a scale Standard Deviation 1.18	-0.80 units on a scale Standard Deviation 1.16	-0.50 units on a scale Standard Deviation 1.03
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Scaling(Trunk)(n=340,345,74,76)	-1.61 units on a scale Standard Deviation 1.28	-1.95 units on a scale Standard Deviation 1.16	-0.93 units on a scale Standard Deviation 1.24	-0.66 units on a scale Standard Deviation 1.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Scaling(Trunk)(n=327,338,74,76)	-1.81 units on a scale Standard Deviation 1.26	-2.04 units on a scale Standard Deviation 1.12	-1.46 units on a scale Standard Deviation 1.21	-1.39 units on a scale Standard Deviation 1.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Scaling(Trunk)(n=305,327,69,72)	-1.92 units on a scale Standard Deviation 1.18	-2.07 units on a scale Standard Deviation 1.19	-1.80 units on a scale Standard Deviation 1.37	-1.88 units on a scale Standard Deviation 1.29
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Scaling(Trunk)(n=213,263,46,55)	-2.15 units on a scale Standard Deviation 1.20	-2.25 units on a scale Standard Deviation 1.10	-2.33 units on a scale Standard Deviation 1.16	-2.18 units on a scale Standard Deviation 1.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Scaling(Trunk)(n=194,239,38,42)	-2.13 units on a scale Standard Deviation 1.20	-2.30 units on a scale Standard Deviation 1.03	-2.18 units on a scale Standard Deviation 1.11	-2.14 units on a scale Standard Deviation 1.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Scaling(Lower limbs)(n=369,367,73,76)	-0.49 units on a scale Standard Deviation 0.74	-0.56 units on a scale Standard Deviation 0.75	-0.32 units on a scale Standard Deviation 0.66	-0.36 units on a scale Standard Deviation 0.69
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Scaling(Lower limbs)(n=354,356,74,76)	-1.34 units on a scale Standard Deviation 1.15	-1.69 units on a scale Standard Deviation 1.19	-0.69 units on a scale Standard Deviation 0.99	-0.62 units on a scale Standard Deviation 0.92
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Scaling(Lower limbs)(n=347,348,74,76)	-1.52 units on a scale Standard Deviation 1.23	-1.97 units on a scale Standard Deviation 1.20	-0.73 units on a scale Standard Deviation 1.08	-0.72 units on a scale Standard Deviation 1.11
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Scaling(Lower limbs)(n=340,345,74,76)	-1.64 units on a scale Standard Deviation 1.29	-2.05 units on a scale Standard Deviation 1.28	-0.86 units on a scale Standard Deviation 1.20	-0.68 units on a scale Standard Deviation 1.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Scaling(Lower limbs)(n=327,338,74,76)	-1.84 units on a scale Standard Deviation 1.26	-2.16 units on a scale Standard Deviation 1.29	-1.59 units on a scale Standard Deviation 1.12	-1.53 units on a scale Standard Deviation 1.23
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Scaling(Lower limbs)(n=305,327,69,72)	-1.96 units on a scale Standard Deviation 1.27	-2.22 units on a scale Standard Deviation 1.33	-1.81 units on a scale Standard Deviation 1.26	-2.15 units on a scale Standard Deviation 1.26
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Scaling(Lower limbs)(n=213,263,46,55)	-2.31 units on a scale Standard Deviation 1.21	-2.48 units on a scale Standard Deviation 1.16	-2.22 units on a scale Standard Deviation 1.26	-2.38 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Scaling(Lower limbs)(n=194,239,38,42)	-2.31 units on a scale Standard Deviation 1.23	-2.49 units on a scale Standard Deviation 1.12	-2.29 units on a scale Standard Deviation 1.27	-2.33 units on a scale Standard Deviation 1.32
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Induration(Trunk)(n=354,356,74,76)	-1.15 units on a scale Standard Deviation 1.11	-1.54 units on a scale Standard Deviation 1.10	-0.59 units on a scale Standard Deviation 1.06	-0.38 units on a scale Standard Deviation 0.92
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Induration(Head\Neck)(n=194,239,38,42)	-1.64 units on a scale Standard Deviation 1.12	-1.72 units on a scale Standard Deviation 1.09	-1.74 units on a scale Standard Deviation 1.16	-1.83 units on a scale Standard Deviation 1.08
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 8:Induration(Upper limbs)(n=354,356,74,76)	-1.18 units on a scale Standard Deviation 1.01	-1.46 units on a scale Standard Deviation 1.12	-0.53 units on a scale Standard Deviation 0.89	-0.53 units on a scale Standard Deviation 0.66
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 12:Induration(Upper limbs)(n=347,348,74,76)	-1.42 units on a scale Standard Deviation 1.09	-1.61 units on a scale Standard Deviation 1.14	-0.57 units on a scale Standard Deviation 0.98	-0.64 units on a scale Standard Deviation 0.86
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Induration(Upper limbs)(n=340,345,74,76)	-1.51 units on a scale Standard Deviation 1.19	-1.68 units on a scale Standard Deviation 1.20	-0.59 units on a scale Standard Deviation 1.19	-0.70 units on a scale Standard Deviation 0.91
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 20:Induration(Upper limbs)(n=327,338,74,76)	-1.64 units on a scale Standard Deviation 1.17	-1.79 units on a scale Standard Deviation 1.20	-1.23 units on a scale Standard Deviation 1.10	-1.49 units on a scale Standard Deviation 1.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 28:Induration(Upper limbs)(n=305,327,69,72)	-1.69 units on a scale Standard Deviation 1.13	-1.79 units on a scale Standard Deviation 1.23	-1.55 units on a scale Standard Deviation 1.18	-1.94 units on a scale Standard Deviation 1.24
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 40:Induration(Upper limbs)(n=213,263,46,55)	-2.04 units on a scale Standard Deviation 1.06	-2.05 units on a scale Standard Deviation 1.09	-1.91 units on a scale Standard Deviation 1.15	-2.20 units on a scale Standard Deviation 1.11
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 52:Induration(Upper limbs)(n=194,239,38,42)	-2.00 units on a scale Standard Deviation 1.09	-2.10 units on a scale Standard Deviation 1.02	-1.87 units on a scale Standard Deviation 1.09	-2.29 units on a scale Standard Deviation 1.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 2:Induration(Trunk)(n=369,367,73,76)	-0.36 units on a scale Standard Deviation 0.64	-0.50 units on a scale Standard Deviation 0.70	-0.16 units on a scale Standard Deviation 0.47	-0.26 units on a scale Standard Deviation 0.60
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Week 16:Induration(Trunk)(n=340,345,74,76)	-1.52 units on a scale Standard Deviation 1.31	-1.94 units on a scale Standard Deviation 1.19	-0.68 units on a scale Standard Deviation 1.26	-0.54 units on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 2	-18.21 percent change Standard Error 1.10	-22.15 percent change Standard Error 1.10	-5.07 percent change Standard Error 2.46	-11.41 percent change Standard Error 2.42
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 4	-34.62 percent change Standard Error 1.44	-42.21 percent change Standard Error 1.44	-14.25 percent change Standard Error 3.20	-14.41 percent change Standard Error 3.17
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 8	-50.36 percent change Standard Error 1.64	-61.31 percent change Standard Error 1.64	-22.18 percent change Standard Error 3.64	-17.40 percent change Standard Error 3.59
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 12	-57.96 percent change Standard Error 1.73	-69.63 percent change Standard Error 1.73	-24.39 percent change Standard Error 3.82	-19.37 percent change Standard Error 3.77
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 40	-67.88 percent change Standard Error 1.90	-75.71 percent change Standard Error 1.83	-60.94 percent change Standard Error 4.06	-72.19 percent change Standard Error 3.95
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 16	-62.06 percent change Standard Error 1.81	-73.21 percent change Standard Error 1.80	-25.91 percent change Standard Error 3.97	-22.50 percent change Standard Error 3.92
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 20	-67.66 percent change Standard Error 1.60	-77.82 percent change Standard Error 1.59	-51.51 percent change Standard Error 3.48	-57.68 percent change Standard Error 3.44
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 28	-71.71 percent change Standard Error 1.59	-79.17 percent change Standard Error 1.56	-65.89 percent change Standard Error 3.40	-76.28 percent change Standard Error 3.36
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 52	-63.98 percent change Standard Error 2.10	-71.82 percent change Standard Error 2.02	-56.64 percent change Standard Error 4.54	-69.52 percent change Standard Error 4.42

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Total Body Surface Area (BSA) With Psoriasis Week 2 (n=369,367,73,76)	28.25 percentage of BSA Standard Deviation 17.19	26.40 percentage of BSA Standard Deviation 16.27	30.63 percentage of BSA Standard Deviation 18.36	29.59 percentage of BSA Standard Deviation 17.47
Total Body Surface Area (BSA) With Psoriasis Week 4 (n=363,366,74,75)	25.09 percentage of BSA Standard Deviation 17.39	21.98 percentage of BSA Standard Deviation 16.48	29.46 percentage of BSA Standard Deviation 18.50	29.48 percentage of BSA Standard Deviation 17.49
Total Body Surface Area (BSA) With Psoriasis Week 8 (n=354,356,74,76)	19.03 percentage of BSA Standard Deviation 15.59	15.63 percentage of BSA Standard Deviation 15.38	26.95 percentage of BSA Standard Deviation 17.78	28.07 percentage of BSA Standard Deviation 18.12
Total Body Surface Area (BSA) With Psoriasis Week 12 (n=354,356,74,76)	15.54 percentage of BSA Standard Deviation 15.88	11.46 percentage of BSA Standard Deviation 14.23	25.67 percentage of BSA Standard Deviation 18.51	26.80 percentage of BSA Standard Deviation 17.99
Total Body Surface Area (BSA) With Psoriasis Week 28 (n=305,327,69,72)	9.24 percentage of BSA Standard Deviation 13.29	6.04 percentage of BSA Standard Deviation 10.70	11.23 percentage of BSA Standard Deviation 13.23	9.53 percentage of BSA Standard Deviation 15.33
Total Body Surface Area (BSA) With Psoriasis Week 40 (n=213,263,46,55)	5.24 percentage of BSA Standard Deviation 9.66	3.66 percentage of BSA Standard Deviation 7.68	6.91 percentage of BSA Standard Deviation 13.56	4.52 percentage of BSA Standard Deviation 8.56
Total Body Surface Area (BSA) With Psoriasis Baseline (n=376,374,74,76)	30.94 percentage of BSA Standard Deviation 17.97	28.49 percentage of BSA Standard Deviation 16.27	30.10 percentage of BSA Standard Deviation 17.97	30.27 percentage of BSA Standard Deviation 17.98
Total Body Surface Area (BSA) With Psoriasis Week 16 (n=340,345,74,76)	13.40 percentage of BSA Standard Deviation 16.30	9.11 percentage of BSA Standard Deviation 12.62	24.95 percentage of BSA Standard Deviation 19.27	26.04 percentage of BSA Standard Deviation 17.73
Total Body Surface Area (BSA) With Psoriasis Week 20 (n=327,338,74,76)	11.56 percentage of BSA Standard Deviation 15.60	7.16 percentage of BSA Standard Deviation 11.11	18.71 percentage of BSA Standard Deviation 16.89	17.65 percentage of BSA Standard Deviation 16.84
Total Body Surface Area (BSA) With Psoriasis Week 52 (n=194,239,38,42)	4.37 percentage of BSA Standard Deviation 7.69	3.32 percentage of BSA Standard Deviation 7.23	4.91 percentage of BSA Standard Deviation 7.48	3.32 percentage of BSA Standard Deviation 5.62

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N'(number of participants analyzed) signifies the unique participants in the longitudinal model.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=371 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=370 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 2	-7.62 percent change Standard Error 0.91	-7.80 percent change Standard Error 0.91	1.77 percent change Standard Error 2.04	-1.13 percent change Standard Error 2.00
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 4	-18.73 percent change Standard Error 1.44	-23.68 percent change Standard Error 1.44	-2.52 percent change Standard Error 3.21	-1.70 percent change Standard Error 3.18
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 8	-36.67 percent change Standard Error 1.86	-46.76 percent change Standard Error 1.86	-10.57 percent change Standard Error 4.12	-4.57 percent change Standard Error 4.07
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 12	-47.94 percent change Standard Error 1.98	-60.67 percent change Standard Error 1.98	-15.27 percent change Standard Error 4.37	-7.55 percent change Standard Error 4.32
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 16	-54.90 percent change Standard Error 2.08	-67.16 percent change Standard Error 2.07	-18.31 percent change Standard Error 4.56	-8.13 percent change Standard Error 4.50
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 20	-61.63 percent change Standard Error 1.98	-74.17 percent change Standard Error 1.97	-37.33 percent change Standard Error 4.30	-38.93 percent change Standard Error 4.24
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 28	-68.41 percent change Standard Error 1.84	-77.92 percent change Standard Error 1.81	-57.91 percent change Standard Error 3.94	-67.84 percent change Standard Error 3.88
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 40	-69.93 percent change Standard Error 1.86	-77.78 percent change Standard Error 1.79	-61.08 percent change Standard Error 3.98	-70.79 percent change Standard Error 3.86
Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 52	-71.23 percent change Standard Error 1.86	-77.20 percent change Standard Error 1.76	-63.88 percent change Standard Error 4.03	-76.60 percent change Standard Error 3.88

SECONDARY outcome

Timeframe: Week 2, 4, 8,12,16, 20, 28, 40, 52

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 2	9.31 percentage of participants Interval 6.37 to 12.25	12.30 percentage of participants Interval 8.97 to 15.63	2.70 percentage of participants Interval 0.0 to 6.4	6.58 percentage of participants Interval 1.01 to 12.15
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 4	28.19 percentage of participants Interval 23.64 to 32.74	41.44 percentage of participants Interval 36.45 to 46.44	9.46 percentage of participants Interval 2.79 to 16.13	11.84 percentage of participants Interval 4.58 to 19.11
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 8	51.60 percentage of participants Interval 46.54 to 56.65	66.84 percentage of participants Interval 62.07 to 71.62	18.92 percentage of participants Interval 10.0 to 27.84	14.47 percentage of participants Interval 6.56 to 22.38
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 12	61.17 percentage of participants Interval 56.24 to 66.1	72.99 percentage of participants Interval 68.49 to 77.49	25.68 percentage of participants Interval 15.72 to 35.63	15.79 percentage of participants Interval 7.59 to 23.99
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 16	63.30 percentage of participants Interval 58.43 to 68.17	74.33 percentage of participants Interval 69.9 to 78.76	29.73 percentage of participants Interval 19.32 to 40.14	23.68 percentage of participants Interval 14.13 to 33.24
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 20	67.55 percentage of participants Interval 62.82 to 72.29	78.34 percentage of participants Interval 74.17 to 82.52	56.76 percentage of participants Interval 45.47 to 68.04	63.16 percentage of participants Interval 52.31 to 74.0
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 28	68.88 percentage of participants Interval 64.2 to 73.56	77.27 percentage of participants Interval 73.03 to 81.52	70.27 percentage of participants Interval 59.86 to 80.68	76.32 percentage of participants Interval 66.76 to 85.87
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 40	53.46 percentage of participants Interval 48.42 to 58.5	67.65 percentage of participants Interval 62.91 to 72.39	56.76 percentage of participants Interval 45.47 to 68.04	69.74 percentage of participants Interval 59.41 to 80.07
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 52	48.67 percentage of participants Interval 43.62 to 53.72	62.03 percentage of participants Interval 57.11 to 66.95	48.65 percentage of participants Interval 37.26 to 60.04	52.63 percentage of participants Interval 41.41 to 63.86

SECONDARY outcome

Timeframe: Week 2, 4, 8,12,16, 20, 28, 40, 52

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 2	0.27 percentage of participants Interval 0.0 to 0.79	0.27 percentage of participants Interval 0.0 to 0.79	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 4	2.66 percentage of participants Interval 1.03 to 4.29	2.67 percentage of participants Interval 1.04 to 4.31	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 8	9.04 percentage of participants Interval 6.14 to 11.94	15.24 percentage of participants Interval 11.6 to 18.88	4.05 percentage of participants Interval 0.0 to 8.55	2.63 percentage of participants Interval 0.0 to 6.23
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 12	18.09 percentage of participants Interval 14.19 to 21.98	29.68 percentage of participants Interval 25.05 to 34.31	5.41 percentage of participants Interval 0.25 to 10.56	3.95 percentage of participants Interval 0.0 to 8.33
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 16	24.47 percentage of participants Interval 20.12 to 28.81	38.77 percentage of participants Interval 33.83 to 43.71	9.46 percentage of participants Interval 2.79 to 16.13	3.95 percentage of participants Interval 0.0 to 8.33
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 20	29.52 percentage of participants Interval 24.91 to 34.13	41.98 percentage of participants Interval 36.98 to 46.98	14.86 percentage of participants Interval 6.76 to 22.97	14.47 percentage of participants Interval 6.56 to 22.38
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 28	29.52 percentage of participants Interval 24.91 to 34.13	44.12 percentage of participants Interval 39.09 to 49.15	31.08 percentage of participants Interval 20.54 to 41.63	46.05 percentage of participants Interval 34.85 to 57.26
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 40	28.99 percentage of participants Interval 24.4 to 33.58	40.11 percentage of participants Interval 35.14 to 45.07	27.03 percentage of participants Interval 16.91 to 37.15	43.42 percentage of participants Interval 32.28 to 54.56
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 52	27.39 percentage of participants Interval 22.89 to 31.9	36.36 percentage of participants Interval 31.49 to 41.24	22.97 percentage of participants Interval 13.39 to 32.56	32.89 percentage of participants Interval 22.33 to 43.46

SECONDARY outcome

Timeframe: Week 2, 4, 8,12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 2 (n=369,367,73,76)	0.54 percentage of participants Interval 0.0 to 1.29	1.09 percentage of participants Interval 0.03 to 2.15	1.37 percentage of participants Interval 0.0 to 4.04	1.32 percentage of participants Interval 0.0 to 3.88
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 4 (n=363,366,74,75)	0.83 percentage of participants Interval 0.0 to 1.76	1.09 percentage of participants Interval 0.03 to 2.16	2.70 percentage of participants Interval 0.0 to 6.4	4.00 percentage of participants Interval 0.0 to 8.43
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 8 (n=354,356,74,76)	1.13 percentage of participants Interval 0.03 to 2.23	0.84 percentage of participants Interval 0.0 to 1.79	4.05 percentage of participants Interval 0.0 to 8.55	7.89 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 12 (n=347,348,74,76)	1.15 percentage of participants Interval 0.03 to 2.28	1.15 percentage of participants Interval 0.03 to 2.27	8.11 percentage of participants Interval 1.89 to 14.33	7.89 percentage of participants Interval 1.83 to 13.96
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 16 (n=340,345,74,76)	1.47 percentage of participants Interval 0.19 to 2.75	1.16 percentage of participants Interval 0.03 to 2.29	10.81 percentage of participants Interval 3.74 to 17.89	9.21 percentage of participants Interval 2.71 to 15.71
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 20 (n=327,338,74,76)	0.61 percentage of participants Interval 0.0 to 1.46	0.30 percentage of participants Interval 0.0 to 0.87	4.05 percentage of participants Interval 0.0 to 8.55	1.32 percentage of participants Interval 0.0 to 3.88
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 28 (n=305,327,69,72)	0.66 percentage of participants Interval 0.0 to 1.56	0.31 percentage of participants Interval 0.0 to 0.9	2.90 percentage of participants Interval 0.0 to 6.86	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 40 (n=213,263,46,55)	0.00 percentage of participants Interval 0.0 to 0.0	0.76 percentage of participants Interval 0.0 to 1.81	2.17 percentage of participants Interval 0.0 to 6.39	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 52 (n=194,239,38,42)	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0	0.00 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 8, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=240 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=226 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Nail Psoriasis Severity Index (NAPSI) Score Baseline (n=240,226,43,55)	27.31 units on a scale Standard Deviation 20.45	26.22 units on a scale Standard Deviation 20.35	25.40 units on a scale Standard Deviation 17.60	26.78 units on a scale Standard Deviation 18.67
Nail Psoriasis Severity Index (NAPSI) Score Week 8 (n=226,214,43,55)	22.36 units on a scale Standard Deviation 19.83	21.88 units on a scale Standard Deviation 19.29	21.86 units on a scale Standard Deviation 17.24	25.75 units on a scale Standard Deviation 18.29
Nail Psoriasis Severity Index (NAPSI) Score Week 16 (n=218,205,43,55)	17.17 units on a scale Standard Deviation 16.86	16.58 units on a scale Standard Deviation 18.13	22.53 units on a scale Standard Deviation 18.96	25.69 units on a scale Standard Deviation 18.37
Nail Psoriasis Severity Index (NAPSI) Score Week 20 (n=208,206,43,55)	15.03 units on a scale Standard Deviation 16.97	14.02 units on a scale Standard Deviation 16.70	21.44 units on a scale Standard Deviation 18.32	24.29 units on a scale Standard Deviation 17.30
Nail Psoriasis Severity Index (NAPSI) Score Week 28 (n=193,197,40,53)	11.77 units on a scale Standard Deviation 15.29	11.78 units on a scale Standard Deviation 15.90	15.93 units on a scale Standard Deviation 16.06	17.77 units on a scale Standard Deviation 15.90
Nail Psoriasis Severity Index (NAPSI) Score Week 40 (n=118,148,26,39)	10.11 units on a scale Standard Deviation 15.71	7.95 units on a scale Standard Deviation 13.57	7.73 units on a scale Standard Deviation 11.80	11.31 units on a scale Standard Deviation 13.41
Nail Psoriasis Severity Index (NAPSI) Score Week 52 (n=108,137,21,30)	9.06 units on a scale Standard Deviation 13.43	7.92 units on a scale Standard Deviation 14.32	5.29 units on a scale Standard Deviation 7.12	7.53 units on a scale Standard Deviation 9.35

SECONDARY outcome

Timeframe: Baseline,Week 8, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=240 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=226 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 8(n=226,214,43,55)	-4.33 units on a scale Standard Deviation 11.30	-4.21 units on a scale Standard Deviation 10.80	-3.53 units on a scale Standard Deviation 10.35	-1.04 units on a scale Standard Deviation 8.54
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 16(n=218,205,43,55)	-8.74 units on a scale Standard Deviation 14.02	-9.36 units on a scale Standard Deviation 13.60	-2.86 units on a scale Standard Deviation 12.72	-1.09 units on a scale Standard Deviation 11.07
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 20(n=208,206,43,55)	-10.61 units on a scale Standard Deviation 15.48	-11.50 units on a scale Standard Deviation 14.74	-3.95 units on a scale Standard Deviation 14.31	-2.49 units on a scale Standard Deviation 10.63
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 28(n=193,197,40,53)	-13.86 units on a scale Standard Deviation 14.96	-14.30 units on a scale Standard Deviation 14.75	-9.45 units on a scale Standard Deviation 17.63	-8.91 units on a scale Standard Deviation 12.90
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 40(n=118,148,26,39)	-16.45 units on a scale Standard Deviation 14.80	-18.11 units on a scale Standard Deviation 15.84	-21.50 units on a scale Standard Deviation 17.28	-15.33 units on a scale Standard Deviation 12.60
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 52(n=108,137,21,30)	-17.08 units on a scale Standard Deviation 15.36	-18.13 units on a scale Standard Deviation 15.27	-23.29 units on a scale Standard Deviation 19.97	-19.17 units on a scale Standard Deviation 13.88

SECONDARY outcome

Timeframe: Baseline, Week 8, 16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. 'n' signifies participants evaluable at specified time point for each arm.

Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=240 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=226 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Number of Affected Nails Baseline (n=240,226,43,55)	7.45 nails Standard Deviation 3.03	7.23 nails Standard Deviation 3.20	7.21 nails Standard Deviation 2.77	7.36 nails Standard Deviation 3.08
Number of Affected Nails Week 8 (n=226,214,43,55)	6.50 nails Standard Deviation 3.51	6.65 nails Standard Deviation 3.61	6.98 nails Standard Deviation 3.11	7.56 nails Standard Deviation 2.99
Number of Affected Nails Week 16 (n=218,204,43,55)	5.83 nails Standard Deviation 3.58	5.37 nails Standard Deviation 3.91	6.79 nails Standard Deviation 3.53	7.56 nails Standard Deviation 3.02
Number of Affected Nails Week 20 (n=207,206,43,55)	5.19 nails Standard Deviation 3.66	4.86 nails Standard Deviation 3.89	6.44 nails Standard Deviation 3.80	7.42 nails Standard Deviation 2.99
Number of Affected Nails Week 28 (n=193,197,40,53)	4.42 nails Standard Deviation 3.74	4.23 nails Standard Deviation 3.85	5.38 nails Standard Deviation 4.11	6.40 nails Standard Deviation 3.62
Number of Affected Nails Week 40 (n=118,148,26,39)	3.79 nails Standard Deviation 3.75	3.03 nails Standard Deviation 3.53	3.12 nails Standard Deviation 3.56	4.41 nails Standard Deviation 3.89
Number of Affected Nails Week 52 (n=108,137,21,30)	3.63 nails Standard Deviation 3.70	2.85 nails Standard Deviation 3.73	2.86 nails Standard Deviation 3.45	3.67 nails Standard Deviation 3.74

SECONDARY outcome

Timeframe: Baseline,Week 8,16, 20, 28, 40, 52

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=227 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=217 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 8	-11.95 percent change Standard Error 6.56	0.55 percent change Standard Error 6.73	-14.70 percent change Standard Error 15.06	11.37 percent change Standard Error 13.31
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 16	-21.56 percent change Standard Error 7.65	-25.87 percent change Standard Error 7.83	-10.70 percent change Standard Error 17.32	31.51 percent change Standard Error 15.32
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 20	-24.02 percent change Standard Error 9.50	-35.56 percent change Standard Error 9.65	-12.19 percent change Standard Error 21.30	37.72 percent change Standard Error 18.83
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change Week 28	-46.40 percent change Standard Error 6.80	-53.80 percent change Standard Error 6.85	-31.97 percent change Standard Error 15.17	5.38 percent change Standard Error 13.34
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change Week 40	-54.22 percent change Standard Error 5.70	-60.39 percent change Standard Error 5.39	-67.71 percent change Standard Error 12.43	-51.65 percent change Standard Error 10.52
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change Week 52	-56.38 percent change Standard Error 5.55	-65.06 percent change Standard Error 5.17	-69.87 percent change Standard Error 12.46	-72.94 percent change Standard Error 10.57

SECONDARY outcome

Timeframe: Week 8, 16, 20, 28, 40, 52

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=240 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=226 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 8	10.83 percentage of participants Interval 6.9 to 14.77	11.95 percentage of participants Interval 7.72 to 16.18	6.98 percentage of participants Interval 0.0 to 14.59	1.82 percentage of participants Interval 0.0 to 5.35
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 16	18.75 percentage of participants Interval 13.81 to 23.69	26.99 percentage of participants Interval 21.2 to 32.78	16.28 percentage of participants Interval 5.24 to 27.31	5.45 percentage of participants Interval 0.0 to 11.46
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 20	24.17 percentage of participants Interval 18.75 to 29.58	33.19 percentage of participants Interval 27.05 to 39.33	23.26 percentage of participants Interval 10.63 to 35.88	7.27 percentage of participants Interval 0.41 to 14.14
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 28	34.58 percentage of participants Interval 28.57 to 40.6	39.82 percentage of participants Interval 33.44 to 46.21	32.56 percentage of participants Interval 18.55 to 46.56	18.18 percentage of participants Interval 7.99 to 28.38
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 40	24.58 percentage of participants Interval 19.14 to 30.03	40.71 percentage of participants Interval 34.3 to 47.11	44.19 percentage of participants Interval 29.34 to 59.03	38.18 percentage of participants Interval 25.34 to 51.02
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 52	23.75 percentage of participants Interval 18.37 to 29.13	40.71 percentage of participants Interval 34.3 to 47.11	39.53 percentage of participants Interval 24.92 to 54.15	29.09 percentage of participants Interval 17.09 to 41.09

SECONDARY outcome

Timeframe: Week 8,16, 20, 28, 40, 52

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=240 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=226 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=43 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=55 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 8	7.92 percentage of participants Interval 4.5 to 11.33	7.52 percentage of participants Interval 4.08 to 10.96	2.33 percentage of participants Interval 0.0 to 6.83	1.82 percentage of participants Interval 0.0 to 5.35
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 16	10.42 percentage of participants Interval 6.55 to 14.28	16.37 percentage of participants Interval 11.55 to 21.2	11.63 percentage of participants Interval 2.05 to 21.21	5.45 percentage of participants Interval 0.0 to 11.46
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 20	14.17 percentage of participants Interval 9.75 to 18.58	21.68 percentage of participants Interval 16.31 to 27.05	16.28 percentage of participants Interval 5.24 to 27.31	3.64 percentage of participants Interval 0.0 to 8.58
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 28	18.75 percentage of participants Interval 13.81 to 23.69	25.22 percentage of participants Interval 19.56 to 30.88	23.26 percentage of participants Interval 10.63 to 35.88	12.73 percentage of participants Interval 3.92 to 21.54
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 40	17.08 percentage of participants Interval 12.32 to 21.84	25.66 percentage of participants Interval 19.97 to 31.36	23.26 percentage of participants Interval 10.63 to 35.88	20.00 percentage of participants Interval 9.43 to 30.57
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 52	17.08 percentage of participants Interval 12.32 to 21.84	29.65 percentage of participants Interval 23.69 to 35.6	20.93 percentage of participants Interval 8.77 to 33.09	20.00 percentage of participants Interval 9.43 to 30.57

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Itch Severity Item (ISI) Score Baseline (n=364,361,74,71)	5.70 units on a scale Standard Deviation 2.65	5.51 units on a scale Standard Deviation 2.64	5.32 units on a scale Standard Deviation 2.66	5.08 units on a scale Standard Deviation 2.58
Itch Severity Item (ISI) Score Week 2 (n=369,367,73,76)	3.88 units on a scale Standard Deviation 2.66	3.47 units on a scale Standard Deviation 2.61	5.01 units on a scale Standard Deviation 2.72	4.66 units on a scale Standard Deviation 2.50
Itch Severity Item (ISI) Score Week 4 (n=364,365,74,75)	3.22 units on a scale Standard Deviation 2.61	2.45 units on a scale Standard Deviation 2.36	4.64 units on a scale Standard Deviation 3.05	4.83 units on a scale Standard Deviation 2.64
Itch Severity Item (ISI) Score Week 8 (n=354,354,74,76)	2.79 units on a scale Standard Deviation 2.68	1.89 units on a scale Standard Deviation 2.33	4.77 units on a scale Standard Deviation 2.96	4.95 units on a scale Standard Deviation 2.79
Itch Severity Item (ISI) Score Week 12 (n=347,349,74,76)	2.55 units on a scale Standard Deviation 2.75	1.77 units on a scale Standard Deviation 2.38	4.46 units on a scale Standard Deviation 2.94	5.01 units on a scale Standard Deviation 2.95
Itch Severity Item (ISI) Score Week 16 (n=340,345,74,76)	2.31 units on a scale Standard Deviation 2.59	1.68 units on a scale Standard Deviation 2.38	4.84 units on a scale Standard Deviation 3.19	5.17 units on a scale Standard Deviation 3.07
Itch Severity Item (ISI) Score Week 20 (n=327,338,74,76)	2.06 units on a scale Standard Deviation 2.52	1.44 units on a scale Standard Deviation 2.16	2.28 units on a scale Standard Deviation 2.47	2.42 units on a scale Standard Deviation 2.43
Itch Severity Item (ISI) Score Week 28 (n=304,326,68,72)	2.05 units on a scale Standard Deviation 2.53	1.52 units on a scale Standard Deviation 2.21	1.93 units on a scale Standard Deviation 2.51	1.51 units on a scale Standard Deviation 2.42
Itch Severity Item (ISI) Score Week 40 (n=212,262,46,55)	1.58 units on a scale Standard Deviation 2.30	1.34 units on a scale Standard Deviation 2.01	1.89 units on a scale Standard Deviation 2.64	1.15 units on a scale Standard Deviation 2.09
Itch Severity Item (ISI) Score Week52 (n=194,238,38,42)	1.62 units on a scale Standard Deviation 2.31	1.15 units on a scale Standard Deviation 1.80	1.82 units on a scale Standard Deviation 2.55	1.19 units on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=361 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=359 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=71 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 2	-1.72 units on a scale Standard Error 0.11	-2.05 units on a scale Standard Error 0.11	-0.44 units on a scale Standard Error 0.24	-0.63 units on a scale Standard Error 0.25
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 4	-2.39 units on a scale Standard Error 0.12	-3.05 units on a scale Standard Error 0.12	-0.78 units on a scale Standard Error 0.26	-0.43 units on a scale Standard Error 0.26
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 8	-2.84 units on a scale Standard Error 0.13	-3.63 units on a scale Standard Error 0.13	-0.64 units on a scale Standard Error 0.27	-0.31 units on a scale Standard Error 0.28
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 12	-2.99 units on a scale Standard Error 0.13	-3.68 units on a scale Standard Error 0.13	-0.95 units on a scale Standard Error 0.28	-0.21 units on a scale Standard Error 0.29
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 16	-3.15 units on a scale Standard Error 0.13	-3.78 units on a scale Standard Error 0.13	-0.58 units on a scale Standard Error 0.29	-0.00 units on a scale Standard Error 0.30
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 20	-3.37 units on a scale Standard Error 0.13	-3.97 units on a scale Standard Error 0.13	-3.13 units on a scale Standard Error 0.27	-2.87 units on a scale Standard Error 0.28
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 28	-3.35 units on a scale Standard Error 0.13	-3.88 units on a scale Standard Error 0.13	-3.32 units on a scale Standard Error 0.28	-3.79 units on a scale Standard Error 0.29
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 40	-3.23 units on a scale Standard Error 0.15	-3.59 units on a scale Standard Error 0.15	-2.97 units on a scale Standard Error 0.33	-3.69 units on a scale Standard Error 0.32
Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 52	-3.03 units on a scale Standard Error 0.16	-3.62 units on a scale Standard Error 0.15	-2.71 units on a scale Standard Error 0.36	-3.14 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Dermatology Life Quality Index (DLQI) Score Baseline (n=376,371,74,76)	13.22 units on a scale Standard Deviation 7.21	12.69 units on a scale Standard Deviation 7.18	13.05 units on a scale Standard Deviation 7.09	12.12 units on a scale Standard Deviation 7.01
Dermatology Life Quality Index (DLQI) Score Week 2 (n=369,367,73,76)	9.07 units on a scale Standard Deviation 6.51	8.02 units on a scale Standard Deviation 6.25	10.37 units on a scale Standard Deviation 7.09	9.51 units on a scale Standard Deviation 5.86
Dermatology Life Quality Index (DLQI) Score Week 4 (n=362,365,74,75)	7.54 units on a scale Standard Deviation 6.40	5.70 units on a scale Standard Deviation 5.48	9.61 units on a scale Standard Deviation 7.42	9.47 units on a scale Standard Deviation 6.45
Dermatology Life Quality Index (DLQI) Score Week 8 (n=352,354,74,76)	6.44 units on a scale Standard Deviation 6.35	4.50 units on a scale Standard Deviation 5.37	8.99 units on a scale Standard Deviation 6.91	9.68 units on a scale Standard Deviation 6.45
Dermatology Life Quality Index (DLQI) Score Week 12 (n=346,346,74,76)	5.91 units on a scale Standard Deviation 6.29	3.72 units on a scale Standard Deviation 5.03	8.28 units on a scale Standard Deviation 6.74	10.25 units on a scale Standard Deviation 6.91
Dermatology Life Quality Index (DLQI) Score Week 16 (n=338,342,74,76)	5.53 units on a scale Standard Deviation 5.93	3.55 units on a scale Standard Deviation 4.93	8.95 units on a scale Standard Deviation 8.12	10.03 units on a scale Standard Deviation 7.33
Dermatology Life Quality Index (DLQI) Score Week 20 (n=327,338,74,76)	4.82 units on a scale Standard Deviation 5.46	3.29 units on a scale Standard Deviation 4.80	4.91 units on a scale Standard Deviation 5.33	5.97 units on a scale Standard Deviation 6.07
Dermatology Life Quality Index (DLQI) Score Week 28 (n=301,324,68,70)	4.50 units on a scale Standard Deviation 5.19	2.97 units on a scale Standard Deviation 4.65	3.78 units on a scale Standard Deviation 5.22	4.29 units on a scale Standard Deviation 6.20
Dermatology Life Quality Index (DLQI) Score Week 40 (n=210,256,46,54)	3.27 units on a scale Standard Deviation 4.71	2.32 units on a scale Standard Deviation 4.00	4.30 units on a scale Standard Deviation 6.50	2.94 units on a scale Standard Deviation 4.85
Dermatology Life Quality Index (DLQI) Score Week 52 (n=194,238,38,42)	3.25 units on a scale Standard Deviation 4.48	2.21 units on a scale Standard Deviation 3.87	4.32 units on a scale Standard Deviation 5.85	2.95 units on a scale Standard Deviation 5.07

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=372 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=368 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 2	-3.98 units on a scale Standard Error 0.22	-4.70 units on a scale Standard Error 0.22	-2.56 units on a scale Standard Error 0.50	-2.95 units on a scale Standard Error 0.49
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 4	-5.50 units on a scale Standard Error 0.24	-6.89 units on a scale Standard Error 0.24	-3.35 units on a scale Standard Error 0.53	-3.00 units on a scale Standard Error 0.53
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 40	-8.23 units on a scale Standard Error 0.31	-9.38 units on a scale Standard Error 0.30	-7.75 units on a scale Standard Error 0.67	-8.31 units on a scale Standard Error 0.65
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 52	-8.18 units on a scale Standard Error 0.32	-9.43 units on a scale Standard Error 0.30	-7.30 units on a scale Standard Error 0.70	-8.01 units on a scale Standard Error 0.67
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 8	-6.63 units on a scale Standard Error 0.27	-8.08 units on a scale Standard Error 0.27	-3.97 units on a scale Standard Error 0.59	-2.78 units on a scale Standard Error 0.58
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 12	-7.03 units on a scale Standard Error 0.28	-8.73 units on a scale Standard Error 0.28	-4.67 units on a scale Standard Error 0.61	-2.21 units on a scale Standard Error 0.61
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 16	-7.24 units on a scale Standard Error 0.29	-8.95 units on a scale Standard Error 0.30	-4.01 units on a scale Standard Error 0.64	-2.44 units on a scale Standard Error 0.64
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 20	-7.93 units on a scale Standard Error 0.28	-9.21 units on a scale Standard Error 0.27	-8.05 units on a scale Standard Error 0.60	-6.49 units on a scale Standard Error 0.59
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 Change at Week 28	-8.20 units on a scale Standard Error 0.29	-9.44 units on a scale Standard Error 0.29	-8.80 units on a scale Standard Error 0.63	-8.07 units on a scale Standard Error 0.62

SECONDARY outcome

Timeframe: Baseline, Week 16, 28, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Baseline:Physical Health(n=375,371,74,76)	46.80 units on a scale Standard Deviation 9.59	47.25 units on a scale Standard Deviation 9.05	47.39 units on a scale Standard Deviation 9.42	47.90 units on a scale Standard Deviation 9.57
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Baseline: Mental Health(n=375,371,74,76)	43.24 units on a scale Standard Deviation 12.04	43.40 units on a scale Standard Deviation 12.54	42.98 units on a scale Standard Deviation 12.43	43.30 units on a scale Standard Deviation 12.57
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 16:Physical Health(n=337,337,74,76)	51.11 units on a scale Standard Deviation 8.12	51.40 units on a scale Standard Deviation 8.45	50.03 units on a scale Standard Deviation 9.56	48.39 units on a scale Standard Deviation 10.29
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 16:Mental Health (n=337,337,74,76)	47.32 units on a scale Standard Deviation 10.61	49.07 units on a scale Standard Deviation 9.72	45.96 units on a scale Standard Deviation 11.56	44.65 units on a scale Standard Deviation 11.62
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 28:Physical Health(n=300,322,68,72)	51.85 units on a scale Standard Deviation 7.81	51.79 units on a scale Standard Deviation 8.70	52.27 units on a scale Standard Deviation 8.18	50.34 units on a scale Standard Deviation 9.58
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 28:Mental Health(n=300,322,68,72)	47.81 units on a scale Standard Deviation 10.83	49.52 units on a scale Standard Deviation 10.29	48.06 units on a scale Standard Deviation 9.17	46.67 units on a scale Standard Deviation 10.86
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 52:Mental Health(n=194,237,38,42)	49.46 units on a scale Standard Deviation 10.18	49.99 units on a scale Standard Deviation 9.45	46.44 units on a scale Standard Deviation 9.84	50.87 units on a scale Standard Deviation 8.31
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 52:Physical health(n=194,237,38,42)	52.38 units on a scale Standard Deviation 7.25	52.94 units on a scale Standard Deviation 7.92	53.00 units on a scale Standard Deviation 7.66	51.48 units on a scale Standard Deviation 8.71

SECONDARY outcome

Timeframe: Baseline, Week 8, 16, 28, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Hospital Anxiety and Depression Scale (HADS) Score Baseline:Anxiety subcale(n=376,371,74,76)	7.05 units on a scale Standard Deviation 4.14	6.94 units on a scale Standard Deviation 4.36	7.72 units on a scale Standard Deviation 4.31	6.38 units on a scale Standard Deviation 4.14
Hospital Anxiety and Depression Scale (HADS) Score Baseline:Depression subcale(n=376,371,74,76)	6.00 units on a scale Standard Deviation 4.42	5.64 units on a scale Standard Deviation 4.16	5.85 units on a scale Standard Deviation 4.38	5.51 units on a scale Standard Deviation 3.79
Hospital Anxiety and Depression Scale (HADS) Score Week 8:Anxiety subcale(n=351,354,74,76)	5.65 units on a scale Standard Deviation 4.00	5.15 units on a scale Standard Deviation 3.59	6.45 units on a scale Standard Deviation 3.81	6.47 units on a scale Standard Deviation 4.06
Hospital Anxiety and Depression Scale (HADS) Score Week 8:Depression subcale(n=351,354,74,76)	4.68 units on a scale Standard Deviation 3.91	3.72 units on a scale Standard Deviation 3.35	4.95 units on a scale Standard Deviation 4.02	5.03 units on a scale Standard Deviation 3.75
Hospital Anxiety and Depression Scale (HADS) Score Week 16:Anxiety(n=337,340,74,76)	5.43 units on a scale Standard Deviation 4.08	5.18 units on a scale Standard Deviation 4.00	5.43 units on a scale Standard Deviation 3.80	5.55 units on a scale Standard Deviation 4.22
Hospital Anxiety and Depression Scale (HADS) Score Week 16:Depression(n=337,340,74,76)	4.36 units on a scale Standard Deviation 4.06	3.50 units on a scale Standard Deviation 3.32	4.49 units on a scale Standard Deviation 4.20	5.21 units on a scale Standard Deviation 3.94
Hospital Anxiety and Depression Scale (HADS) Score Week 28:Anxiety(n=300,322,68,72)	4.86 units on a scale Standard Deviation 3.92	4.71 units on a scale Standard Deviation 3.85	4.96 units on a scale Standard Deviation 4.26	5.10 units on a scale Standard Deviation 4.11
Hospital Anxiety and Depression Scale (HADS) Score Week 28:Depression(n=300,322,68,72)	4.03 units on a scale Standard Deviation 3.97	3.20 units on a scale Standard Deviation 3.29	3.68 units on a scale Standard Deviation 3.91	4.65 units on a scale Standard Deviation 3.82
Hospital Anxiety and Depression Scale (HADS) Score Week 52:Anxiety(n=194,237,38,42)	4.36 units on a scale Standard Deviation 3.94	4.32 units on a scale Standard Deviation 3.68	4.89 units on a scale Standard Deviation 4.57	4.10 units on a scale Standard Deviation 3.53
Hospital Anxiety and Depression Scale (HADS) Score Week 52:Depression(n=194,237,38,42)	3.62 units on a scale Standard Deviation 3.84	3.14 units on a scale Standard Deviation 3.22	3.29 units on a scale Standard Deviation 3.50	2.95 units on a scale Standard Deviation 3.11

SECONDARY outcome

Timeframe: Baseline, Week 8, 16, 28, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 \[no loss\] to 100 \[complete loss of work\]).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Work Limitation Questionnaire (WLQ) Index Score Baseline (n=324,318,66,68)	7.77 units on a scale Standard Deviation 5.94	8.26 units on a scale Standard Deviation 6.59	7.63 units on a scale Standard Deviation 5.65	7.78 units on a scale Standard Deviation 6.32
Work Limitation Questionnaire (WLQ) Index Score Week 8 (n=293,302,63,61)	6.89 units on a scale Standard Deviation 6.79	6.99 units on a scale Standard Deviation 6.68	7.04 units on a scale Standard Deviation 6.41	8.53 units on a scale Standard Deviation 7.11
Work Limitation Questionnaire (WLQ) Index Score Week 16 (n=278,292,64,61)	6.28 units on a scale Standard Deviation 6.31	6.44 units on a scale Standard Deviation 6.48	7.27 units on a scale Standard Deviation 6.97	7.14 units on a scale Standard Deviation 6.46
Work Limitation Questionnaire (WLQ) Index Score Week 28 (n=249,277,56,61)	5.93 units on a scale Standard Deviation 6.03	5.71 units on a scale Standard Deviation 5.64	6.11 units on a scale Standard Deviation 6.76	7.45 units on a scale Standard Deviation 7.27
Work Limitation Questionnaire (WLQ) Index Score Week 52 (n=164,205,31,38)	5.86 units on a scale Standard Deviation 6.35	5.79 units on a scale Standard Deviation 6.03	6.48 units on a scale Standard Deviation 6.41	5.23 units on a scale Standard Deviation 5.97

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe).

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline:Clear(n=376,372,74,76)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline:Mild(n=376,372,74,76)	4.3 percentage of participants	3.0 percentage of participants	2.7 percentage of participants	2.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline:Moderate(n=376,372,74,76)	33.2 percentage of participants	32.8 percentage of participants	41.9 percentage of participants	34.2 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline:Severe(n=376,372,74,76)	62.0 percentage of participants	64.2 percentage of participants	55.4 percentage of participants	63.2 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week2:Almost Clear(n=369,366,73,76)	2.2 percentage of participants	2.2 percentage of participants	1.4 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2:Severe(n=369,366,73,76)	34.4 percentage of participants	31.4 percentage of participants	45.2 percentage of participants	50.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4:Clear(n=363,365,74,75)	0.6 percentage of participants	0.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4:Almost clear(n=363,365,74,75)	7.4 percentage of participants	13.7 percentage of participants	5.4 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4:Severe(n=363,365,74,75)	23.4 percentage of participants	17.3 percentage of participants	37.8 percentage of participants	46.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8:Clear(n=352,354,74,76)	1.7 percentage of participants	4.2 percentage of participants	4.1 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8:Mild(n=352,354,74,76)	29.5 percentage of participants	30.8 percentage of participants	16.2 percentage of participants	10.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8:Moderate(n=352,354,74,76)	32.1 percentage of participants	22.6 percentage of participants	47.3 percentage of participants	40.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12:Clear(n=346,345,74,76)	4.3 percentage of participants	11.0 percentage of participants	2.7 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12:Almost Clear(n=346,345,74,76)	30.1 percentage of participants	43.8 percentage of participants	8.1 percentage of participants	2.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12:Mild(n=346,345,74,76)	24.9 percentage of participants	19.7 percentage of participants	20.3 percentage of participants	7.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12:Severe(n=346,345,74,76)	13.9 percentage of participants	7.2 percentage of participants	31.1 percentage of participants	46.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16:Clear(n=337,342,74,75)	6.2 percentage of participants	14.0 percentage of participants	6.8 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16:Mild(n=n=337,342,74,75)	27.9 percentage of participants	21.9 percentage of participants	20.3 percentage of participants	14.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20:Clear(n=327,338,73,76)	8.9 percentage of participants	15.7 percentage of participants	9.6 percentage of participants	1.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20:Almost Clear(n=327,338,73,76)	33.6 percentage of participants	43.8 percentage of participants	13.7 percentage of participants	18.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20:Mild(n=327,338,73,76)	25.4 percentage of participants	21.3 percentage of participants	39.7 percentage of participants	34.2 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20:Moderate(n=327,338,73,76)	23.5 percentage of participants	12.7 percentage of participants	28.8 percentage of participants	30.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20:Severe(n=327,338,73,76)	8.6 percentage of participants	6.5 percentage of participants	8.2 percentage of participants	15.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28:Clear(n=300,324,68,72)	11.3 percentage of participants	21.3 percentage of participants	19.1 percentage of participants	12.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28:Almost Clear(n=300,324,68,72)	34.3 percentage of participants	43.5 percentage of participants	36.8 percentage of participants	43.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28:Mild(n=300,324,68,72)	26.3 percentage of participants	17.6 percentage of participants	17.6 percentage of participants	18.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40:Clear(n=210,255,46,54)	21.0 percentage of participants	26.3 percentage of participants	21.7 percentage of participants	20.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40:Mild(n=210,255,46,54)	22.9 percentage of participants	16.9 percentage of participants	19.6 percentage of participants	13.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40:Severe(n=210,255,46,54)	3.3 percentage of participants	2.4 percentage of participants	8.7 percentage of participants	7.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52:Clear(n=194,238,38,42)	14.4 percentage of participants	26.9 percentage of participants	26.3 percentage of participants	21.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52:Almost Clear(n=194,238,38,42)	44.8 percentage of participants	45.4 percentage of participants	26.3 percentage of participants	52.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week2:Mild(n=369,366,73,76)	13.6 percentage of participants	21.0 percentage of participants	12.3 percentage of participants	7.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week2:Moderate(n=369,366,73,76)	49.9 percentage of participants	45.4 percentage of participants	41.1 percentage of participants	42.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4:Mild(n=363,365,74,75)	22.3 percentage of participants	35.3 percentage of participants	10.8 percentage of participants	12.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week4:Moderate(n=363,365,74,75)	46.3 percentage of participants	33.4 percentage of participants	45.9 percentage of participants	41.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8:Almost clear(n=352,354,74,76)	19.9 percentage of participants	32.5 percentage of participants	1.4 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8:Severe(n=352,354,74,76)	16.8 percentage of participants	9.9 percentage of participants	31.1 percentage of participants	48.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12:Moderate(n=346,345,74,76)	26.9 percentage of participants	18.3 percentage of participants	37.8 percentage of participants	43.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16:Almost clear(n=337,342,74,75)	30.9 percentage of participants	41.8 percentage of participants	2.7 percentage of participants	2.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16:Moderate(n=n=337,342,74,75)	21.4 percentage of participants	16.7 percentage of participants	39.2 percentage of participants	34.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16:Severe(n=n=337,342,74,75)	13.6 percentage of participants	5.6 percentage of participants	31.1 percentage of participants	48.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline:Almost Clear(n=376,372,74,76)	0.5 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2:Clear(n=369,366,73,76)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28:Moderate(n=300,324,68,72)	22.0 percentage of participants	12.0 percentage of participants	17.6 percentage of participants	18.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28:Severe(n=300,324,68,72)	6.0 percentage of participants	5.6 percentage of participants	8.8 percentage of participants	8.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Almost Clear(n=210,255,46,54)	40.0 percentage of participants	45.9 percentage of participants	37.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40:Moderate(n=210,255,46,54)	12.9 percentage of participants	8.6 percentage of participants	13.0 percentage of participants	9.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52:Mild(n=194,238,38,42)	24.2 percentage of participants	16.8 percentage of participants	28.9 percentage of participants	11.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52:Moderate(n=194,238,38,42)	12.9 percentage of participants	8.8 percentage of participants	13.2 percentage of participants	7.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52:Severe(n=194,238,38,42)	3.6 percentage of participants	2.1 percentage of participants	5.3 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: Week 16, 28, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week16:Not satisfied/dissatisfied(n=337,339,74,76)	4.7 percentage of Participants	3.8 percentage of Participants	17.6 percentage of Participants	15.8 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Slightly dissatisfied(n=337,339,74,76)	3.3 percentage of Participants	1.5 percentage of Participants	6.8 percentage of Participants	3.9 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Somewhat dissatisfied(n=337,339,74,76)	5.3 percentage of Participants	1.5 percentage of Participants	12.2 percentage of Participants	15.8 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Slightly satisfied(n=300,320,68,72)	11.0 percentage of Participants	5.6 percentage of Participants	11.8 percentage of Participants	9.7 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week28:Not satisfied/dissatisfied(n=300,320,68,72)	3.0 percentage of Participants	2.5 percentage of Participants	4.4 percentage of Participants	4.2 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Very dissatisfied(n=300,320,68,72)	3.3 percentage of Participants	1.9 percentage of Participants	4.4 percentage of Participants	4.2 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Slightly dissatisfied(n=194,237,38,42)	1.5 percentage of Participants	1.7 percentage of Participants	0 percentage of Participants	2.4 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Somewhat dissatisfied(n=194,237,38,42)	2.6 percentage of Participants	0.8 percentage of Participants	5.3 percentage of Participants	0 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Very dissatisfied(n=194,237,38,42)	1.0 percentage of Participants	0.8 percentage of Participants	2.6 percentage of Participants	2.4 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Very satisfied(n=337,339,74,76)	48.4 percentage of Participants	60.5 percentage of Participants	10.8 percentage of Participants	17.1 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Somewhat satisfied(n=337,339,74,76)	24.9 percentage of Participants	23.9 percentage of Participants	20.3 percentage of Participants	14.5 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Slightly satisfied(n=337,339,74,76)	8.0 percentage of Participants	5.6 percentage of Participants	10.8 percentage of Participants	13.2 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Very dissatisfied(n=337,339,74,76)	5.3 percentage of Participants	3.2 percentage of Participants	21.6 percentage of Participants	19.7 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Very satisfied(n=300,320,68,72)	48.7 percentage of Participants	58.8 percentage of Participants	45.6 percentage of Participants	54.2 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Somewhat satisfied(n=300,320,68,72)	28.0 percentage of Participants	26.3 percentage of Participants	25.0 percentage of Participants	19.4 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Slightly dissatisfied(n=300,320,68,72)	3.3 percentage of Participants	2.2 percentage of Participants	5.9 percentage of Participants	5.6 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Somewhat dissatisfied(n=300,320,68,72)	2.7 percentage of Participants	2.8 percentage of Participants	2.9 percentage of Participants	2.8 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Very satisfied(n=194,237,38,42)	57.7 percentage of Participants	62.9 percentage of Participants	50.0 percentage of Participants	71.4 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Somewhat satisfied(n=194,237,38,42)	29.4 percentage of Participants	27.8 percentage of Participants	28.9 percentage of Participants	16.7 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Slightly satisfied(n=194,237,38,42)	6.2 percentage of Participants	4.6 percentage of Participants	10.5 percentage of Participants	4.8 percentage of Participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week52:Not satisfied/dissatisfied(n=194,237,38,42)	1.5 percentage of Participants	1.3 percentage of Participants	2.6 percentage of Participants	2.4 percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 8,16, 28, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain".

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Joint Pain Assessment (JPA) Score Baseline (n=376,372,74,76)	3.79 units on a scale Standard Deviation 3.13	3.44 units on a scale Standard Deviation 3.09	3.45 units on a scale Standard Deviation 2.89	2.96 units on a scale Standard Deviation 3.05
Joint Pain Assessment (JPA) Score Week 8 (n=351,354,74,76)	2.50 units on a scale Standard Deviation 2.56	2.22 units on a scale Standard Deviation 2.58	2.86 units on a scale Standard Deviation 2.91	3.14 units on a scale Standard Deviation 3.00
Joint Pain Assessment (JPA) Score Week 16 (n=336,340,74,76)	2.24 units on a scale Standard Deviation 2.59	1.95 units on a scale Standard Deviation 2.41	2.88 units on a scale Standard Deviation 2.93	3.21 units on a scale Standard Deviation 3.16
Joint Pain Assessment (JPA) Score Week 28 (n=300,320,68,72)	2.25 units on a scale Standard Deviation 2.64	1.78 units on a scale Standard Deviation 2.40	2.15 units on a scale Standard Deviation 2.62	2.26 units on a scale Standard Deviation 2.64
Joint Pain Assessment (JPA) Score Week 52 (n=193,235,38,42)	1.88 units on a scale Standard Deviation 2.41	1.74 units on a scale Standard Deviation 2.30	2.00 units on a scale Standard Deviation 2.63	1.64 units on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: Baseline, Week 16, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, 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

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Baseline (n=376,372,74,76)	0.76 units on a scale Standard Deviation 0.20	0.78 units on a scale Standard Deviation 0.18	0.79 units on a scale Standard Deviation 0.15	0.80 units on a scale Standard Deviation 0.19
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 16 (n=337,340,74,76)	0.85 units on a scale Standard Deviation 0.16	0.88 units on a scale Standard Deviation 0.14	0.82 units on a scale Standard Deviation 0.17	0.80 units on a scale Standard Deviation 0.20
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 40 (n=210,256,46,54)	0.90 units on a scale Standard Deviation 0.13	0.91 units on a scale Standard Deviation 0.12	0.91 units on a scale Standard Deviation 0.10	0.88 units on a scale Standard Deviation 0.18
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 28 (n=300,322,68,72)	0.86 units on a scale Standard Deviation 0.16	0.88 units on a scale Standard Deviation 0.15	0.88 units on a scale Standard Deviation 0.15	0.86 units on a scale Standard Deviation 0.16
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 52 (n=194,237,38,42)	0.89 units on a scale Standard Deviation 0.12	0.89 units on a scale Standard Deviation 0.14	0.90 units on a scale Standard Deviation 0.10	0.87 units on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline,Week 16, 28, 40, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=74 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=76 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Baseline (n=373,372,74,76)	65.83 mm Standard Deviation 24.04	67.38 mm Standard Deviation 24.21	63.82 mm Standard Deviation 23.66	65.05 mm Standard Deviation 25.63
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 16 (n=337,339,74,76)	76.19 mm Standard Deviation 18.80	78.43 mm Standard Deviation 17.59	72.24 mm Standard Deviation 20.76	70.14 mm Standard Deviation 22.19
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 28 (n=300,322,69,72)	78.48 mm Standard Deviation 17.46	80.65 mm Standard Deviation 15.31	77.00 mm Standard Deviation 20.77	77.53 mm Standard Deviation 17.49
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 52 (n=195,238,38,42)	81.95 mm Standard Deviation 15.91	81.48 mm Standard Deviation 15.53	78.00 mm Standard Deviation 19.11	81.52 mm Standard Deviation 20.60
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 40 (n=210,255,46,54)	81.40 mm Standard Deviation 17.42	82.27 mm Standard Deviation 15.69	79.70 mm Standard Deviation 19.17	82.78 mm Standard Deviation 18.58

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from a site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=67 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=68 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=30 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:General Practitioner(n=45,45,24)	4 events	5 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Dermatologist(n=45,45,24)	44 events	44 events	22 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Rheumatologist(n=45,45,24)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Cardiologist(n=45,45,24)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Gastroenterologist(n=45,45,24)	0 events	1 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Psychiatrist(n=45,45,24)	1 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Surgeon(n=45,45,24)	0 events	0 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Nurse(n=45,45,24)	15 events	16 events	8 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline:Other(n=45,45,24)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:General Practitioner(n=67,68,30)	31 events	34 events	17 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Dermatologist(n=67,68,30)	25 events	25 events	9 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Rheumatologist(n=67,68,30)	3 events	1 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Cardiologist(n=67,68,30)	5 events	0 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Gastroenterologist(n=67,68,30)	1 events	1 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Psychiatrist(n=67,68,30)	1 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Surgeon(n=67,68,30)	5 events	2 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Nurse(n=67,68,30)	14 events	11 events	5 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16:Others(n=67,68,30)	18 events	14 events	16 events	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed \[Emp\]) answered (Yes/No \[Y/N\]): "Were you absent or on sick leave from work due to psoriasis today?", and participants (unemployed \[UEmp\]) answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline:Emp,Absent/Sick Leave:Y(n=218,234,122)	50 participants	59 participants	27 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline:Emp,Absent/Sick Leave:N(n=218,234,122)	168 participants	175 participants	95 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline:UEmp,due to Psoriasis:Y(n=120,97,52)	28 participants	16 participants	10 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline:UEmp,due to Psoriasis:N(n=120,97,52)	92 participants	81 participants	42 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16:Emp,Absent/Sick Leave:Y(n=210,234,109)	45 participants	53 participants	25 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16:Emp,Absent/Sick Leave:N(n=210,234,109)	165 participants	181 participants	84 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16:UEmp,due to Psoriasis:Y(n=105,80,38)	21 participants	10 participants	8 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16:UEmp,due to Psoriasis:N(n=105,80,38)	84 participants	70 participants	30 participants	—

SECONDARY outcome

Timeframe: Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Healthcare Resource use events(n=34,42,12)	100.00 percentage of participants	100.00 percentage of participants	100.00 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Work Impacted events due to Psoriasis(n=105,80,39)	20.00 percentage of participants	12.50 percentage of participants	20.51 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Absence/Sick leave due to Psoriasis(n=211,234,109)	21.33 percentage of participants	22.65 percentage of participants	22.94 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Employment(n=315,315,146)	66.67 percentage of participants	74.60 percentage of participants	74.66 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure for specified parameter for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=50 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=59 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=27 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Week 16:Hours Scheduled to work(n=45,53,25)	8.82 hours Standard Deviation 2.20	8.40 hours Standard Deviation 1.75	8.04 hours Standard Deviation 1.72	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Baseline:Hour Absent from work(n=49,58,27)	5.86 hours Standard Deviation 4.24	5.74 hours Standard Deviation 3.01	5.74 hours Standard Deviation 2.78	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Week 16:Hours Absent from work(n=45,53,25)	5.93 hours Standard Deviation 3.26	6.21 hours Standard Deviation 3.15	5.96 hours Standard Deviation 3.13	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Baseline:Hour Scheduled to work(n=50,59,27)	8.84 hours Standard Deviation 3.02	8.56 hours Standard Deviation 2.74	8.07 hours Standard Deviation 1.71	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable for specified timepoint for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=48 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=58 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=27 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours Baseline (n=48, 58, 27)	64.89 percentage of scheduled hours Standard Deviation 34.42	70.32 percentage of scheduled hours Standard Deviation 35.39	73.36 percentage of scheduled hours Standard Deviation 34.09	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours Week 16 (n=45, 53, 25)	68.39 percentage of scheduled hours Standard Deviation 32.19	72.88 percentage of scheduled hours Standard Deviation 29.69	73.82 percentage of scheduled hours Standard Deviation 34.05	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies participants evaluable at specified time point for each arm, respectively.

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=376 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=374 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=193 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work Baseline (n=223, 232, 124)	2.50 units on a scale Standard Deviation 3.06	2.61 units on a scale Standard Deviation 2.99	2.32 units on a scale Standard Deviation 2.99	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work Week 16 (n=210, 234, 109)	1.15 units on a scale Standard Deviation 2.18	0.85 units on a scale Standard Deviation 1.94	2.07 units on a scale Standard Deviation 3.21	—

SECONDARY outcome

Timeframe: Baseline, Week 16, 52

Population: FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.

The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	CP-690,550 5mg n=41 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=47 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=14 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.	Placebo, Then CP-690,550 10 mg n=11 Participants Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
Family Dermatology Life Quality Index (FDLQI) Score Baseline (n=41,47,14,11)	9.20 units on a scale Standard Deviation 6.65	9.57 units on a scale Standard Deviation 6.78	8.07 units on a scale Standard Deviation 6.26	6.27 units on a scale Standard Deviation 4.50
Family Dermatology Life Quality Index (FDLQI) Score Week 16 (n=36,32,11,9)	4.17 units on a scale Standard Deviation 4.48	2.84 units on a scale Standard Deviation 3.48	6.09 units on a scale Standard Deviation 4.41	7.33 units on a scale Standard Deviation 6.02
Family Dermatology Life Quality Index (FDLQI) Score Week52 (n=13,12,4,4)	3.08 units on a scale Standard Deviation 5.22	2.33 units on a scale Standard Deviation 2.90	1.75 units on a scale Standard Deviation 3.50	2.00 units on a scale Standard Deviation 1.41

Adverse Events

CP-690,550 5mg

Serious events: 18 serious events

Other events: 207 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 19 serious events

Other events: 213 other events

Deaths: 0 deaths

Placebo, Then CP-690,550 5 mg

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo, Then CP-690,550 10 mg

Serious events: 6 serious events

Other events: 54 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 5mg n=382 participants at risk CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=381 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo, Then CP-690,550 5 mg n=75 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.	Placebo, Then CP-690,550 10 mg n=77 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=44 participants at risk Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
Cardiac disorders Atrial fibrillation	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Atrial flutter	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Cardiac arrest	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Myocardial infarction	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Palpitations	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Pancreatitis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
General disorders Drug withdrawal syndrome	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Acute sinusitis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Appendicitis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Chronic tonsillitis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Erysipelas	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Herpes zoster	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Influenza	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Liver abscess	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Localised infection	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pneumonia	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pneumonia cryptococcal	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Sepsis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Staphylococcal sepsis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Tooth infection	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Ankle fracture	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Joint dislocation	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Hepatic enzyme increased	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Back pain	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Cerebrovascular accident	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Schizophrenia	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Suicide attempt	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Reproductive system and breast disorders Menorrhagia	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Reproductive system and breast disorders Metrorrhagia	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.52% 2/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Psoriasis	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Surgical and medical procedures Jaw lesion excision	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Vascular disorders Hypertensive crisis	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.

Other adverse events

Other adverse events
Measure	CP-690,550 5mg n=382 participants at risk CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=381 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo, Then CP-690,550 5 mg n=75 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.	Placebo, Then CP-690,550 10 mg n=77 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=44 participants at risk Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
Gastrointestinal disorders Nausea	2.4% 9/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.4% 9/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Blood and lymphatic system disorders Lymphadenopathy	2.4% 9/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 10/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Ear and labyrinth disorders Vertigo	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Eye disorders Dry eye	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Abdominal pain	1.8% 7/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Abdominal pain upper	1.8% 7/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 5/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Constipation	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Diarrhoea	5.8% 22/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.2% 16/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Gastritis	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.79% 3/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Haematochezia	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
General disorders Chest pain	0.79% 3/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.0% 3/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
General disorders Influenza like illness	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.79% 3/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Bronchitis	2.1% 8/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Folliculitis	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.6% 6/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Gastroenteritis	2.1% 8/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Influenza	1.3% 5/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.1% 12/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Nasopharyngitis	12.6% 48/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	13.9% 53/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	13.3% 10/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	9.1% 7/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.5% 2/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Oral herpes	1.6% 6/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pharyngitis	2.1% 8/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.6% 6/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.9% 3/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Respiratory tract infection	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 5/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Sinusitis	1.6% 6/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.0% 3/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Skin infection	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Tinea pedis	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.79% 3/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Tooth abscess	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Upper respiratory tract infection	7.6% 29/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	7.9% 30/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.7% 5/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	11.7% 9/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Urinary tract infection	2.4% 9/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.4% 9/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Infections and infestations Viral infection	1.0% 4/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Joint injury	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.52% 2/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Alanine aminotransferase increased	1.6% 6/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 10/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.3% 4/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.9% 3/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Aspartate aminotransferase increased	1.3% 5/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.0% 4/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.0% 3/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Blood cholesterol increased	2.4% 9/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.6% 6/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.2% 4/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Blood creatine phosphokinase increased	4.7% 18/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.8% 26/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.3% 4/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	9.1% 7/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Blood triglycerides increased	2.6% 10/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.8% 7/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.2% 4/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Gamma-glutamyltransferase increased	1.8% 7/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.1% 8/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.3% 4/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.2% 4/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Low density lipoprotein increased	3.1% 12/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.4% 9/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Investigations Weight increased	2.6% 10/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.5% 17/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hypercholesterolaemia	6.3% 24/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.6% 25/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.0% 3/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	7.8% 6/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hyperlipidaemia	2.1% 8/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.4% 9/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.0% 4/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.79% 3/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 16/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.7% 18/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.3% 4/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.9% 3/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Arthritis	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.52% 2/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Back pain	4.2% 16/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 5/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.3% 4/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.5% 5/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Myalgia	0.79% 3/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.6% 6/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 5/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.52% 2/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Dizziness	1.8% 7/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 5/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.0% 3/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.9% 3/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Headache	5.8% 22/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.6% 25/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	8.0% 6/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	5.2% 4/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Depressed mood	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.26% 1/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Insomnia	0.26% 1/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.52% 2/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 9/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	4.5% 17/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 10/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.1% 12/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Acne	0.79% 3/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 10/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	3.9% 3/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Pruritus	2.1% 8/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 5/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Psoriasis	0.52% 2/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.0% 4/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.3% 1/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	6.8% 3/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Social circumstances Treatment noncompliance	0.00% 0/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.3% 1/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.
Vascular disorders Hypertension	3.4% 13/382 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	1.8% 7/381 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.7% 2/75 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	2.6% 2/77 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.	0.00% 0/44 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=44) who were not re-randomized at week 16, are reported separately.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER