Trial Outcomes & Findings for A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis (NCT NCT01276639)

NCT ID: NCT01276639

Last Updated: 2014-09-19

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 901 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

Measure	CP-690,550 5 mg 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 thereafter 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	363	361	177	0	0
Week 0 to 16 Treated	363	360	177	0	0
Week 0 to 16 COMPLETED	313	320	132	0	0
Week 0 to 16 NOT COMPLETED	50	41	45	0	0
Week 16 to 52 STARTED	313	320	0	66	66
Week 16 to 52 COMPLETED	186	219	0	50	45
Week 16 to 52 NOT COMPLETED	127	101	0	16	21

Reasons for withdrawal

Measure	CP-690,550 5 mg 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 thereafter 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	0	0	0
Week 0 to 16 Adverse Event	11	8	11	0	0
Week 0 to 16 Lack of Efficacy	20	15	25	0	0
Week 0 to 16 Lost to Follow-up	3	5	3	0	0
Week 0 to 16 Withdrawal by Subject	8	5	4	0	0
Week 0 to 16 Other	7	7	2	0	0
Week 0 to 16 Randomized, But Not Treated	0	1	0	0	0
Week 16 to 52 Death	1	0	0	0	0
Week 16 to 52 Adverse Event	10	13	0	1	3
Week 16 to 52 Lack of Efficacy	99	71	0	14	13
Week 16 to 52 Lost to Follow-up	3	1	0	0	1
Week 16 to 52 Withdrawal by Subject	4	4	0	0	1
Week 16 to 52 Other	10	12	0	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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=900 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 13.4 • n=5 Participants	45.2 years STANDARD_DEVIATION 12.8 • n=7 Participants	45.0 years STANDARD_DEVIATION 12.6 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.0 • n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	99 Participants n=7 Participants	56 Participants n=5 Participants	257 Participants n=4 Participants
Sex: Female, Male Male	261 Participants n=5 Participants	261 Participants n=7 Participants	121 Participants n=5 Participants	643 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set (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). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.

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).

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	41.87 percentage of participants	59.17 percentage of participants	9.04 percentage of participants	—

PRIMARY outcome

Timeframe: 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). NRI method (participants with missing values considered as non-responders) was used to impute missing values.

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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	39.94 percentage of participants	59.17 percentage of participants	6.21 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). 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

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	-51.94 percent change Standard Error 2.45	-67.20 percent change Standard Error 2.44	1.62 percent change Standard Error 3.59	—

SECONDARY outcome

Timeframe: 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). NRI method (participants with missing values considered as non-responders) was used to impute missing values.

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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	19.83 percentage of participants	39.44 percentage of participants	0.56 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline

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). 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

Measure	CP-690,550 5 mg n=363 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=177 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, 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	12.46 units on a scale Standard Deviation 6.89	12.87 units on a scale Standard Deviation 6.91	14.01 units on a scale Standard Deviation 7.06	—

SECONDARY outcome

Timeframe: Week 4, 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). 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

Measure	CP-690,550 5 mg n=358 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=357 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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 16	-6.91 units on a scale Standard Error 0.30	-8.90 units on a scale Standard Error 0.29	-1.93 units on a scale Standard Error 0.44	—
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 Change at Week 4	-5.59 units on a scale Standard Error 0.25	-6.40 units on a scale Standard Error 0.25	-1.69 units on a scale Standard Error 0.35	—

SECONDARY outcome

Timeframe: Week 4

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). NRI method (participants with missing values considered as non-responders) was used to impute missing values.

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).

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	17.08 percentage of participants	23.06 percentage of participants	2.26 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

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). NRI method (participants with missing values considered as non-responders) was used to impute missing values.

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 75% reduction in PASI relative to Baseline.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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 4	10.47 percentage of participants	15.56 percentage of participants	1.69 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). Here 'N' (number of participants analyzed) signifies those 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

Measure	CP-690,550 5 mg n=237 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=242 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=102 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, 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	-14.15 percent change Standard Error 9.47	-41.48 percent change Standard Error 9.22	55.55 percent change Standard Error 14.84	—

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

Measure	CP-690,550 5 mg n=151 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=209 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, 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	60.17 percent probability of response Interval 51.8 to 67.56	71.56 percent probability of response Interval 64.81 to 77.24	—	—

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

Measure	CP-690,550 5 mg n=145 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=209 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, 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	73.75 percent probability of response Interval 65.47 to 80.33	79.94 percent probability of response Interval 73.75 to 84.82	—	—

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

Measure	CP-690,550 5 mg n=72 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, 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	61.79 percent probability of response Interval 49.37 to 72.01	70.58 percent probability of response Interval 62.12 to 77.49	—	—

SECONDARY outcome

Timeframe: Baseline up to 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). 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

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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'	16.0 weeks Interval 12.0 to Upper limit was not estimable based on the log-log transformation method.	12.0 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 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). Here 'N' (number of participants analyzed) 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 75 response was defined as at least 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

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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	NA 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 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). Here 'N' (number of participants analyzed) 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

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). 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. NRI method was used to impute missing values.

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).

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 52	35.54 percentage of participants Interval 30.61 to 40.46	46.67 percentage of participants Interval 41.51 to 51.82	43.94 percentage of participants Interval 31.97 to 55.91	59.09 percentage of participants Interval 47.23 to 70.95
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 2	5.23 percentage of participants Interval 2.94 to 7.53	10.00 percentage of participants Interval 6.9 to 13.1	3.03 percentage of participants Interval 0.0 to 7.17	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 4	17.08 percentage of participants Interval 13.21 to 20.95	23.06 percentage of participants Interval 18.7 to 27.41	6.06 percentage of participants Interval 0.3 to 11.82	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 8	31.40 percentage of participants Interval 26.63 to 36.18	46.39 percentage of participants Interval 41.24 to 51.54	9.09 percentage of participants Interval 2.16 to 16.03	6.06 percentage of participants Interval 0.3 to 11.82
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 12	37.74 percentage of participants Interval 32.75 to 42.73	56.67 percentage of participants Interval 51.55 to 61.79	12.12 percentage of participants Interval 4.25 to 20.0	9.09 percentage of participants Interval 2.16 to 16.03
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 16	41.87 percentage of participants Interval 36.8 to 46.95	59.17 percentage of participants Interval 54.09 to 64.24	13.64 percentage of participants Interval 5.36 to 21.92	10.61 percentage of participants Interval 3.18 to 18.03
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 20	45.45 percentage of participants Interval 40.33 to 50.58	56.67 percentage of participants Interval 51.55 to 61.79	39.39 percentage of participants Interval 27.61 to 51.18	30.30 percentage of participants Interval 19.22 to 41.39
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 28	48.76 percentage of participants Interval 43.62 to 53.9	62.22 percentage of participants Interval 57.21 to 67.23	66.67 percentage of participants Interval 55.29 to 78.04	65.15 percentage of participants Interval 53.66 to 76.65
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' Week 40	42.70 percentage of participants Interval 37.61 to 47.79	53.06 percentage of participants Interval 47.9 to 58.21	53.03 percentage of participants Interval 40.99 to 65.07	63.64 percentage of participants Interval 52.03 to 75.24

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. NRI method was used to impute missing values. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

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). Percentage of participants with each PGA score is reported.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 12: Moderate (n = 345, 345, 65, 66)	19.4 percentage of participants	13.0 percentage of participants	41.5 percentage of participants	54.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Severe (n = 363, 360, 66, 66)	11.6 percentage of participants	10.8 percentage of participants	3.0 percentage of participants	7.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Clear (n = 358, 358, 66, 64)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Almost Clear (n = 358, 358, 66, 64)	5.3 percentage of participants	10.1 percentage of participants	3.0 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Mild (n = 358, 358, 66, 64)	32.7 percentage of participants	38.8 percentage of participants	30.3 percentage of participants	18.8 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Mild (n = 352, 350, 65, 66)	43.8 percentage of participants	45.4 percentage of participants	33.8 percentage of participants	21.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Moderate (n = 347, 350, 65, 66)	24.2 percentage of participants	14.6 percentage of participants	53.8 percentage of participants	65.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Severe (n = 323, 335, 66, 66)	2.5 percentage of participants	1.5 percentage of participants	4.5 percentage of participants	6.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Almost Clear (n = 312, 321, 66, 65)	36.5 percentage of participants	32.4 percentage of participants	31.8 percentage of participants	21.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Moderate (n = 203, 242, 53, 57)	4.9 percentage of participants	5.4 percentage of participants	7.5 percentage of participants	2.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Severe (n = 203, 242, 53, 57)	0.5 percentage of participants	0.4 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Mild (n = 345, 345, 65, 66)	38.0 percentage of participants	26.1 percentage of participants	43.1 percentage of participants	25.8 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Almost Clear (n = 345, 345, 65, 66)	31.9 percentage of participants	41.7 percentage of participants	10.8 percentage of participants	9.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Clear (n = 363, 360, 66, 66)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Almost Clear (n = 363, 360, 66, 66)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Mild (n = 363, 360, 66, 66)	0.3 percentage of participants	0.3 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Baseline: Moderate (n = 363, 360, 66, 66)	88.2 percentage of participants	88.9 percentage of participants	97.0 percentage of participants	92.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Moderate (n = 358, 358, 66, 64)	57.0 percentage of participants	46.1 percentage of participants	63.6 percentage of participants	70.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 2: Severe (n = 358, 358, 66, 64)	5.0 percentage of participants	5.0 percentage of participants	3.0 percentage of participants	10.9 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Clear (n = 352, 350, 65, 66)	1.4 percentage of participants	3.4 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Almost Clear (n = 352, 350, 65, 66)	16.2 percentage of participants	20.3 percentage of participants	6.2 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Moderate (n = 352, 350, 65, 66)	35.5 percentage of participants	28.3 percentage of participants	55.4 percentage of participants	71.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 4: Severe (n = 352, 350, 65, 66)	3.1 percentage of participants	2.6 percentage of participants	4.6 percentage of participants	7.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Clear (n = 347, 350, 65, 66)	3.7 percentage of participants	10.6 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Almost Clear (n = 347, 350, 65, 66)	29.1 percentage of participants	37.1 percentage of participants	9.2 percentage of participants	6.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Mild (n = 347, 350, 65, 66)	40.3 percentage of participants	36.0 percentage of participants	33.8 percentage of participants	24.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 8: Severe (n = 347, 350, 65, 66)	2.6 percentage of participants	1.7 percentage of participants	3.1 percentage of participants	4.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Clear (n = 345, 345, 65, 66)	7.8 percentage of participants	17.4 percentage of participants	1.5 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 12: Severe (n = 345, 345, 65, 66)	2.9 percentage of participants	1.7 percentage of participants	3.1 percentage of participants	10.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Clear (n = 323, 335, 66, 66)	12.1 percentage of participants	25.7 percentage of participants	0.00 percentage of participants	3.0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Almost Clear (n = 323, 335, 66, 66)	35.0 percentage of participants	37.9 percentage of participants	13.6 percentage of participants	7.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Mild (n = 323, 335, 66, 66)	32.8 percentage of participants	23.6 percentage of participants	47.0 percentage of participants	21.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 16: Moderate (n = 323, 335, 66, 66)	17.6 percentage of participants	11.3 percentage of participants	34.8 percentage of participants	62.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Mild (n = 203, 242, 53, 57)	18.2 percentage of participants	15.3 percentage of participants	26.4 percentage of participants	8.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Clear (n = 312, 321, 66, 65)	16.3 percentage of participants	31.2 percentage of participants	7.6 percentage of participants	9.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Mild (n = 312, 321, 66, 65)	31.7 percentage of participants	24.3 percentage of participants	53.0 percentage of participants	43.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Moderate (n = 312, 321, 66, 65)	14.7 percentage of participants	11.5 percentage of participants	7.6 percentage of participants	23.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 20: Severe (n = 312, 321, 66, 65)	0.6 percentage of participants	0.6 percentage of participants	0.00 percentage of participants	3.1 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Clear (n = 300, 307, 61, 61)	23.3 percentage of participants	34.2 percentage of participants	14.8 percentage of participants	29.5 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Almost Clear (n = 300, 307, 61, 61)	35.7 percentage of participants	38.8 percentage of participants	57.4 percentage of participants	41.0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Mild (n = 300, 307, 61, 61)	25.7 percentage of participants	17.6 percentage of participants	23.0 percentage of participants	19.7 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Moderate (n = 300, 307, 61, 61)	14.3 percentage of participants	8.8 percentage of participants	4.9 percentage of participants	6.6 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 28: Severe (n = 300, 307, 61, 61)	1.0 percentage of participants	0.7 percentage of participants	0.00 percentage of participants	3.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Clear (n = 203, 242, 53, 57)	35.5 percentage of participants	45.9 percentage of participants	18.9 percentage of participants	55.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 40: Almost Clear (n = 203, 242, 53, 57)	40.9 percentage of participants	33.1 percentage of participants	47.2 percentage of participants	34.0 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Clear (n = 180, 219, 47, 46)	31.7 percentage of participants	43.4 percentage of participants	19.1 percentage of participants	54.3 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Almost Clear (n = 180, 219, 47, 46)	40.0 percentage of participants	33.3 percentage of participants	42.6 percentage of participants	30.4 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Mild (n = 180, 219, 47, 46)	19.4 percentage of participants	19.6 percentage of participants	36.2 percentage of participants	15.2 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Moderate (n = 180, 219, 47, 46)	8.9 percentage of participants	3.7 percentage of participants	2.1 percentage of participants	0.00 percentage of participants
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score Week 52: Severe (n = 180, 219, 47, 46)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants

SECONDARY outcome

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

Population: FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). 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. NRI method was used to impute missing values.

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 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 4	10.47 percentage of participants Interval 7.32 to 13.62	15.56 percentage of participants Interval 11.81 to 19.3	4.55 percentage of participants Interval 0.0 to 9.57	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 40	45.45 percentage of participants Interval 40.33 to 50.58	56.94 percentage of participants Interval 51.83 to 62.06	65.15 percentage of participants Interval 53.66 to 76.65	68.18 percentage of participants Interval 56.94 to 79.42
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 2	1.38 percentage of participants Interval 0.18 to 2.58	2.22 percentage of participants Interval 0.7 to 3.74	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 8	23.69 percentage of participants Interval 19.32 to 28.07	36.67 percentage of participants Interval 31.69 to 41.64	6.06 percentage of participants Interval 0.3 to 11.82	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 12	35.54 percentage of participants Interval 30.61 to 40.46	55.28 percentage of participants Interval 50.14 to 60.41	6.06 percentage of participants Interval 0.3 to 11.82	7.58 percentage of participants Interval 1.19 to 13.96
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 16	39.94 percentage of participants Interval 34.91 to 44.98	59.17 percentage of participants Interval 54.09 to 64.24	9.09 percentage of participants Interval 2.16 to 16.03	7.58 percentage of participants Interval 1.19 to 13.96
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 20	45.18 percentage of participants Interval 40.06 to 50.3	59.44 percentage of participants Interval 54.37 to 64.52	31.82 percentage of participants Interval 20.58 to 43.06	24.24 percentage of participants Interval 13.9 to 34.58
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 28	49.86 percentage of participants Interval 44.72 to 55.01	63.06 percentage of participants Interval 58.07 to 68.04	59.09 percentage of participants Interval 47.23 to 70.95	68.18 percentage of participants Interval 56.94 to 79.42
Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response Week 52	38.84 percentage of participants Interval 33.83 to 43.86	51.39 percentage of participants Interval 46.23 to 56.55	54.55 percentage of participants Interval 42.53 to 66.56	65.15 percentage of participants Interval 53.66 to 76.65

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. 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 "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.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 Baseline (n=363,360,66,66)	21.95 units on a scale Standard Deviation 8.99	22.73 units on a scale Standard Deviation 8.82	21.19 units on a scale Standard Deviation 8.54	23.03 units on a scale Standard Deviation 8.66
Psoriasis Area and Severity Index (PASI) Score Week 2 (n=358,358,66,64)	18.28 units on a scale Standard Deviation 9.63	17.30 units on a scale Standard Deviation 9.06	19.81 units on a scale Standard Deviation 10.28	22.11 units on a scale Standard Deviation 9.84
Psoriasis Area and Severity Index (PASI) Score Week 4 (n=352,350,65,66)	14.39 units on a scale Standard Deviation 8.75	13.10 units on a scale Standard Deviation 8.90	18.36 units on a scale Standard Deviation 10.86	20.63 units on a scale Standard Deviation 9.26
Psoriasis Area and Severity Index (PASI) Score Week 8 (n=347,350,65,66)	11.41 units on a scale Standard Deviation 9.08	8.97 units on a scale Standard Deviation 8.00	17.17 units on a scale Standard Deviation 10.32	20.13 units on a scale Standard Deviation 10.15
Psoriasis Area and Severity Index (PASI) Score Week 12 (n=345,345,65,66)	9.85 units on a scale Standard Deviation 9.38	6.94 units on a scale Standard Deviation 7.59	16.52 units on a scale Standard Deviation 10.45	19.38 units on a scale Standard Deviation 10.07
Psoriasis Area and Severity Index (PASI) Score Week 16 (n=323,335,66,66)	8.42 units on a scale Standard Deviation 9.05	5.74 units on a scale Standard Deviation 7.21	16.08 units on a scale Standard Deviation 10.41	19.71 units on a scale Standard Deviation 11.25
Psoriasis Area and Severity Index (PASI) Score Week 20 (n=312,321,66,65)	6.82 units on a scale Standard Deviation 7.23	4.95 units on a scale Standard Deviation 6.30	9.18 units on a scale Standard Deviation 7.21	11.79 units on a scale Standard Deviation 8.38
Psoriasis Area and Severity Index (PASI) Score Week 28 (n=300,307,61,61)	5.80 units on a scale Standard Deviation 6.87	4.01 units on a scale Standard Deviation 5.28	5.20 units on a scale Standard Deviation 5.95	5.23 units on a scale Standard Deviation 6.42
Psoriasis Area and Severity Index (PASI) Score Week 40 (n=203,242,53,47)	3.05 units on a scale Standard Deviation 3.71	2.64 units on a scale Standard Deviation 3.85	3.22 units on a scale Standard Deviation 3.70	1.64 units on a scale Standard Deviation 2.27
Psoriasis Area and Severity Index (PASI) Score Week 52 (n=180,219,47,46)	3.28 units on a scale Standard Deviation 3.71	2.47 units on a scale Standard Deviation 3.21	3.16 units on a scale Standard Deviation 3.22	1.64 units on a scale Standard Deviation 2.01

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. Here 'N' (number of participants analyzed) 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.

Outcome measures

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 20	-14.36 units on a scale Standard Error 0.44	-17.11 units on a scale Standard Error 0.44	-12.41 units on a scale Standard Error 1.00	-11.18 units on a scale Standard Error 1.00
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	-15.15 units on a scale Standard Error 0.47	-17.51 units on a scale Standard Error 0.46	-16.16 units on a scale Standard Error 1.03	-18.54 units on a scale Standard Error 1.05
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	-3.87 units on a scale Standard Error 0.29	-5.31 units on a scale Standard Error 0.29	-1.79 units on a scale Standard Error 0.66	-0.81 units on a scale Standard Error 0.67
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	-7.61 units on a scale Standard Error 0.35	-9.48 units on a scale Standard Error 0.35	-3.14 units on a scale Standard Error 0.81	-2.18 units on a scale Standard Error 0.81
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	-10.61 units on a scale Standard Error 0.41	-13.58 units on a scale Standard Error 0.41	-4.45 units on a scale Standard Error 0.95	-2.68 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 12	-12.02 units on a scale Standard Error 0.44	-15.62 units on a scale Standard Error 0.44	-4.97 units on a scale Standard Error 1.02	-3.43 units on a scale Standard Error 1.02
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	-12.90 units on a scale Standard Error 0.48	-16.55 units on a scale Standard Error 0.48	-5.51 units on a scale Standard Error 1.09	-3.10 units on a scale Standard Error 1.09
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	-15.53 units on a scale Standard Error 0.44	-18.02 units on a scale Standard Error 0.43	-16.21 units on a scale Standard Error 0.98	-17.63 units on a scale Standard Error 0.98
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	-14.70 units on a scale Standard Error 0.48	-17.16 units on a scale Standard Error 0.47	-15.69 units on a scale Standard Error 1.04	-18.62 units on a scale Standard Error 1.06

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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 Baseline: Induration (Head\Neck) (n=363,360,66,66)	2.08 units on a scale Standard Deviation 0.97	1.96 units on a scale Standard Deviation 1.01	2.14 units on a scale Standard Deviation 0.97	2.02 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Scaling (Trunk) (n=363,360,66,66)	2.60 units on a scale Standard Deviation 0.86	2.60 units on a scale Standard Deviation 0.83	2.36 units on a scale Standard Deviation 0.82	2.77 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Scaling (Lower Limbs) (n=363,360,66,66)	2.98 units on a scale Standard Deviation 0.72	2.91 units on a scale Standard Deviation 0.72	2.77 units on a scale Standard Deviation 0.72	2.97 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Induration (Head\Neck) (n=358,358,66,64)	1.70 units on a scale Standard Deviation 1.05	1.48 units on a scale Standard Deviation 1.03	1.94 units on a scale Standard Deviation 0.99	1.92 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Induration (Lower Limbs) (n=358,358,66,64)	2.50 units on a scale Standard Deviation 0.82	2.38 units on a scale Standard Deviation 0.84	2.62 units on a scale Standard Deviation 0.80	2.72 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Scaling (Head\Neck) (n=358,358,66,64)	1.85 units on a scale Standard Deviation 1.11	1.67 units on a scale Standard Deviation 1.11	2.03 units on a scale Standard Deviation 1.07	2.08 units on a scale Standard Deviation 1.13
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Erythema (Upper Limbs) (n=352,350,65,66)	2.00 units on a scale Standard Deviation 0.88	1.85 units on a scale Standard Deviation 0.90	2.42 units on a scale Standard Deviation 0.81	2.73 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Erythema (Lower Limbs) (n=352,350,65,66)	2.35 units on a scale Standard Deviation 0.90	2.15 units on a scale Standard Deviation 0.91	2.78 units on a scale Standard Deviation 0.78	2.97 units on a scale Standard Deviation 0.68
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Induration (Head\Neck) (n=352,350,65,66)	1.28 units on a scale Standard Deviation 0.98	1.11 units on a scale Standard Deviation 0.99	1.74 units on a scale Standard Deviation 1.06	1.74 units on a scale Standard Deviation 1.03
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Induration (Trunk) (n=352,350,65,66)	1.80 units on a scale Standard Deviation 0.95	1.66 units on a scale Standard Deviation 1.00	2.15 units on a scale Standard Deviation 1.03	2.53 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Induration (Head\Neck) (n=347,350,65,66)	1.04 units on a scale Standard Deviation 1.01	0.75 units on a scale Standard Deviation 0.88	1.68 units on a scale Standard Deviation 1.03	1.67 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Induration (Trunk) (n=347,350,65,66)	1.44 units on a scale Standard Deviation 1.02	1.26 units on a scale Standard Deviation 1.02	2.03 units on a scale Standard Deviation 1.07	2.38 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Scaling (Upper Limbs) (n=347,350,65,66)	1.66 units on a scale Standard Deviation 1.02	1.37 units on a scale Standard Deviation 0.96	2.05 units on a scale Standard Deviation 0.78	2.35 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Scaling (Trunk) (n=347,350,65,66)	1.41 units on a scale Standard Deviation 1.09	1.19 units on a scale Standard Deviation 1.05	1.83 units on a scale Standard Deviation 1.01	2.20 units on a scale Standard Deviation 1.06
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Erythema (Head\Neck) (n=312,321,66,65)	0.94 units on a scale Standard Deviation 1.02	0.66 units on a scale Standard Deviation 0.94	1.08 units on a scale Standard Deviation 0.93	1.23 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Scaling (Trunk) (n=358,358,66,64)	2.12 units on a scale Standard Deviation 1.00	2.00 units on a scale Standard Deviation 1.00	2.14 units on a scale Standard Deviation 1.04	2.50 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Erythema (Trunk) (n=323,335,66,66)	1.40 units on a scale Standard Deviation 1.17	1.01 units on a scale Standard Deviation 1.09	2.14 units on a scale Standard Deviation 1.11	2.58 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Scaling (Head\Neck) (n=180,219,47,46)	0.51 units on a scale Standard Deviation 0.77	0.42 units on a scale Standard Deviation 0.78	0.62 units on a scale Standard Deviation 0.87	0.39 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Scaling (Upper Limbs) (n=180,219,47,46)	0.91 units on a scale Standard Deviation 0.97	0.74 units on a scale Standard Deviation 0.88	1.06 units on a scale Standard Deviation 0.87	0.57 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Erythema (Lower Limbs) (n=358,358,66,64)	2.75 units on a scale Standard Deviation 0.81	2.60 units on a scale Standard Deviation 0.83	2.98 units on a scale Standard Deviation 0.64	3.14 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Induration (Upper Limbs) (n=358,358,66,64)	2.27 units on a scale Standard Deviation 0.83	2.11 units on a scale Standard Deviation 0.86	2.36 units on a scale Standard Deviation 0.76	2.58 units on a scale Standard Deviation 0.71
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Induration (Trunk) (n=358,358,66,64)	2.20 units on a scale Standard Deviation 0.90	2.10 units on a scale Standard Deviation 0.92	2.32 units on a scale Standard Deviation 0.90	2.58 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Scaling (Upper Limbs) (n=358,358,66,64)	2.29 units on a scale Standard Deviation 0.93	2.08 units on a scale Standard Deviation 0.91	2.26 units on a scale Standard Deviation 0.75	2.58 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Scaling (Lower Limbs) (n=358,358,66,64)	2.50 units on a scale Standard Deviation 0.91	2.33 units on a scale Standard Deviation 0.92	2.53 units on a scale Standard Deviation 0.85	2.75 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Erythema (Head\Neck) (n=352,350,65,66)	1.45 units on a scale Standard Deviation 1.03	1.33 units on a scale Standard Deviation 1.06	1.89 units on a scale Standard Deviation 1.11	1.92 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Erythema (Trunk) (n=352,350,65,66)	1.99 units on a scale Standard Deviation 0.99	1.83 units on a scale Standard Deviation 1.00	2.42 units on a scale Standard Deviation 0.97	2.74 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Erythema (Lower Limbs) (n=323,335,66,66)	1.63 units on a scale Standard Deviation 1.19	1.25 units on a scale Standard Deviation 1.10	2.52 units on a scale Standard Deviation 0.83	2.82 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Induration (Upper Limbs) (n=352,350,65,66)	1.87 units on a scale Standard Deviation 0.90	1.73 units on a scale Standard Deviation 0.91	2.25 units on a scale Standard Deviation 0.83	2.53 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Induration (Lower Limbs) (n=352,350,65,66)	2.06 units on a scale Standard Deviation 0.90	1.93 units on a scale Standard Deviation 0.92	2.48 units on a scale Standard Deviation 0.87	2.71 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Scaling (Head\Neck) (n=352,350,65,66)	1.43 units on a scale Standard Deviation 1.10	1.23 units on a scale Standard Deviation 1.07	1.80 units on a scale Standard Deviation 1.16	1.94 units on a scale Standard Deviation 1.07
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Scaling (Upper Limbs) (n=352,350,65,66)	1.88 units on a scale Standard Deviation 0.98	1.71 units on a scale Standard Deviation 0.93	2.14 units on a scale Standard Deviation 0.68	2.42 units on a scale Standard Deviation 0.79
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Scaling (Trunk) (n=352,350,65,66)	1.79 units on a scale Standard Deviation 1.03	1.57 units on a scale Standard Deviation 1.01	1.98 units on a scale Standard Deviation 1.01	2.41 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores Week 4: Scaling (Lower Limbs) (n=352,350,65,66)	2.11 units on a scale Standard Deviation 0.96	1.93 units on a scale Standard Deviation 1.00	2.32 units on a scale Standard Deviation 0.92	2.64 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Erythema (Head\Neck) (n=347,350,65,66)	1.23 units on a scale Standard Deviation 1.05	0.95 units on a scale Standard Deviation 0.98	1.92 units on a scale Standard Deviation 1.11	1.86 units on a scale Standard Deviation 1.05
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Erythema (Upper Limbs) (n=347,350,65,66)	1.76 units on a scale Standard Deviation 0.98	1.48 units on a scale Standard Deviation 0.93	2.43 units on a scale Standard Deviation 0.77	2.61 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Erythema (Trunk) (n=347,350,65,66)	1.67 units on a scale Standard Deviation 1.11	1.37 units on a scale Standard Deviation 1.02	2.31 units on a scale Standard Deviation 1.01	2.55 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Erythema (Lower Limbs) (n=347,350,65,66)	1.99 units on a scale Standard Deviation 1.08	1.71 units on a scale Standard Deviation 0.98	2.62 units on a scale Standard Deviation 0.78	2.91 units on a scale Standard Deviation 0.76
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Induration (Upper Limbs) (n=347,350,65,66)	1.62 units on a scale Standard Deviation 0.93	1.39 units on a scale Standard Deviation 0.93	2.15 units on a scale Standard Deviation 0.80	2.44 units on a scale Standard Deviation 0.70
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Induration (Lower Limbs) (n=347,350,65,66)	1.74 units on a scale Standard Deviation 1.02	1.47 units on a scale Standard Deviation 0.97	2.35 units on a scale Standard Deviation 0.87	2.67 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Scaling (Head\Neck) (n=347,350,65,66)	1.18 units on a scale Standard Deviation 1.12	0.83 units on a scale Standard Deviation 0.97	1.80 units on a scale Standard Deviation 1.11	1.88 units on a scale Standard Deviation 1.09
Psoriasis Area and Severity Index (PASI) Component Scores Week 8: Scaling (Lower Limbs) (n=347,350,65,66)	1.80 units on a scale Standard Deviation 1.07	1.45 units on a scale Standard Deviation 1.03	2.22 units on a scale Standard Deviation 0.96	2.55 units on a scale Standard Deviation 0.91
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Erythema (Head\Neck) (n=345,345,65,66)	1.10 units on a scale Standard Deviation 1.09	0.83 units on a scale Standard Deviation 0.96	1.78 units on a scale Standard Deviation 0.96	1.85 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Erythema (Upper Limbs) (n=345,345,65,66)	1.60 units on a scale Standard Deviation 1.07	1.28 units on a scale Standard Deviation 0.96	2.35 units on a scale Standard Deviation 0.76	2.53 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Erythema (Trunk) (n=345,345,65,66)	1.53 units on a scale Standard Deviation 1.18	1.12 units on a scale Standard Deviation 1.07	2.35 units on a scale Standard Deviation 0.98	2.53 units on a scale Standard Deviation 0.95
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Erythema (Lower Limbs) (n=345,345,65,66)	1.81 units on a scale Standard Deviation 1.13	1.39 units on a scale Standard Deviation 1.06	2.54 units on a scale Standard Deviation 0.79	2.77 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Induration (Head\Neck) (n=345,345,65,66)	0.90 units on a scale Standard Deviation 1.02	0.65 units on a scale Standard Deviation 0.86	1.54 units on a scale Standard Deviation 0.97	1.56 units on a scale Standard Deviation 1.01
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Induration (Upper Limbs)(n=345,345,65,66)	1.48 units on a scale Standard Deviation 1.02	1.17 units on a scale Standard Deviation 0.95	2.05 units on a scale Standard Deviation 0.78	2.32 units on a scale Standard Deviation 0.84
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Induration (Trunk) (n=345,345,65,66)	1.34 units on a scale Standard Deviation 1.09	0.98 units on a scale Standard Deviation 1.03	1.89 units on a scale Standard Deviation 0.99	2.27 units on a scale Standard Deviation 0.99
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Induration (Lower Limbs)(n=345,345,65,66)	1.58 units on a scale Standard Deviation 1.08	1.17 units on a scale Standard Deviation 0.98	2.26 units on a scale Standard Deviation 0.82	2.55 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Scaling (Head\Neck) (n=345,345,65,66)	1.03 units on a scale Standard Deviation 1.06	0.72 units on a scale Standard Deviation 0.91	1.77 units on a scale Standard Deviation 1.01	1.76 units on a scale Standard Deviation 1.10
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Erythema (Trunk) (n=180,219,47,46)	0.64 units on a scale Standard Deviation 0.91	0.59 units on a scale Standard Deviation 0.93	0.66 units on a scale Standard Deviation 0.94	0.50 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Erythema (Lower Limbs) (n=180,219,47,46)	0.93 units on a scale Standard Deviation 1.05	0.67 units on a scale Standard Deviation 0.98	0.87 units on a scale Standard Deviation 0.99	0.63 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Induration (Head\Neck) (n=180,219,47,46)	0.47 units on a scale Standard Deviation 0.71	0.32 units on a scale Standard Deviation 0.66	0.40 units on a scale Standard Deviation 0.68	0.24 units on a scale Standard Deviation 0.57
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Scaling (Upper Limbs) (n=345,345,65,66)	1.50 units on a scale Standard Deviation 1.07	1.18 units on a scale Standard Deviation 0.98	2.03 units on a scale Standard Deviation 0.90	2.27 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Induration (Upper Limbs)(n=180,219,47,46)	0.86 units on a scale Standard Deviation 0.94	0.70 units on a scale Standard Deviation 0.87	0.98 units on a scale Standard Deviation 0.82	0.43 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Induration (Trunk) (n=180,219,47,46)	0.56 units on a scale Standard Deviation 0.81	0.54 units on a scale Standard Deviation 0.86	0.53 units on a scale Standard Deviation 0.80	0.35 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Induration (Lower Limbs)(n=180,219,47,46)	0.84 units on a scale Standard Deviation 0.96	0.61 units on a scale Standard Deviation 0.89	0.79 units on a scale Standard Deviation 0.88	0.39 units on a scale Standard Deviation 0.65
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Scaling (Trunk) (n=345,345,65,66)	1.30 units on a scale Standard Deviation 1.12	0.95 units on a scale Standard Deviation 1.01	1.89 units on a scale Standard Deviation 1.05	2.26 units on a scale Standard Deviation 1.09
Psoriasis Area and Severity Index (PASI) Component Scores Week 12: Scaling (Lower Limbs) (n=345,345,65,66)	1.56 units on a scale Standard Deviation 1.10	1.14 units on a scale Standard Deviation 0.98	2.14 units on a scale Standard Deviation 0.95	2.53 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Erythema (Head\Neck) (n=323,335,66,66)	1.01 units on a scale Standard Deviation 1.07	0.75 units on a scale Standard Deviation 0.95	1.73 units on a scale Standard Deviation 1.05	1.91 units on a scale Standard Deviation 1.09
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Erythema (Upper Limbs) (n=323,335,66,66)	1.46 units on a scale Standard Deviation 1.12	1.13 units on a scale Standard Deviation 1.00	2.30 units on a scale Standard Deviation 0.80	2.53 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Induration (Head\Neck) (n=323,335,66,66)	0.83 units on a scale Standard Deviation 0.97	0.60 units on a scale Standard Deviation 0.88	1.42 units on a scale Standard Deviation 1.01	1.58 units on a scale Standard Deviation 1.12
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Induration (Upper Limbs)(n=323,335,66,66)	1.34 units on a scale Standard Deviation 1.10	1.06 units on a scale Standard Deviation 0.99	2.06 units on a scale Standard Deviation 0.87	2.33 units on a scale Standard Deviation 0.93
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Scaling (Trunk) (n=180,219,47,46)	0.54 units on a scale Standard Deviation 0.81	0.51 units on a scale Standard Deviation 0.79	0.57 units on a scale Standard Deviation 0.83	0.43 units on a scale Standard Deviation 0.81
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Induration (Trunk) (n=323,335,66,66)	1.22 units on a scale Standard Deviation 1.08	0.85 units on a scale Standard Deviation 1.05	1.83 units on a scale Standard Deviation 1.14	2.29 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Induration (Lower Limbs)(n=323,335,66,66)	1.38 units on a scale Standard Deviation 1.07	1.01 units on a scale Standard Deviation 1.02	2.20 units on a scale Standard Deviation 0.92	2.52 units on a scale Standard Deviation 0.86
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Scaling (Lower Limbs) (n=180,219,47,46)	0.89 units on a scale Standard Deviation 0.98	0.58 units on a scale Standard Deviation 0.90	0.91 units on a scale Standard Deviation 0.95	0.50 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Scaling (Head\Neck) (n=323,335,66,66)	0.94 units on a scale Standard Deviation 1.04	0.67 units on a scale Standard Deviation 0.91	1.59 units on a scale Standard Deviation 1.02	1.76 units on a scale Standard Deviation 1.10
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Scaling (Upper Limbs) (n=323,335,66,66)	1.41 units on a scale Standard Deviation 1.09	1.07 units on a scale Standard Deviation 0.98	2.08 units on a scale Standard Deviation 0.90	2.29 units on a scale Standard Deviation 0.89
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Scaling (Trunk) (n=323,335,66,66)	1.15 units on a scale Standard Deviation 1.01	0.84 units on a scale Standard Deviation 0.99	1.83 units on a scale Standard Deviation 1.12	2.12 units on a scale Standard Deviation 1.10
Psoriasis Area and Severity Index (PASI) Component Scores Week 16: Scaling (Lower Limbs) (n=323,335,66,66)	1.42 units on a scale Standard Deviation 1.06	1.01 units on a scale Standard Deviation 1.02	2.15 units on a scale Standard Deviation 1.00	2.50 units on a scale Standard Deviation 1.06
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Erythema (Upper Limbs) (n=312,321,66,65)	1.29 units on a scale Standard Deviation 1.04	1.05 units on a scale Standard Deviation 1.01	1.48 units on a scale Standard Deviation 0.79	1.80 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Erythema (Trunk) (n=312,321,66,65)	1.23 units on a scale Standard Deviation 1.09	0.89 units on a scale Standard Deviation 1.06	1.36 units on a scale Standard Deviation 0.97	1.68 units on a scale Standard Deviation 1.02
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Erythema (Lower Limbs) (n=312,321,66,65)	1.45 units on a scale Standard Deviation 1.17	1.13 units on a scale Standard Deviation 1.09	1.71 units on a scale Standard Deviation 0.82	1.94 units on a scale Standard Deviation 0.98
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Induration (Head\Neck) (n=312,321,66,65)	0.78 units on a scale Standard Deviation 0.93	0.55 units on a scale Standard Deviation 0.83	0.83 units on a scale Standard Deviation 0.83	0.97 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Induration (Upper Limbs)(n=312,321,66,65)	1.21 units on a scale Standard Deviation 1.03	0.99 units on a scale Standard Deviation 1.00	1.38 units on a scale Standard Deviation 0.78	1.52 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Induration (Trunk) (n=312,321,66,65)	1.06 units on a scale Standard Deviation 1.03	0.78 units on a scale Standard Deviation 1.02	1.17 units on a scale Standard Deviation 1.02	1.43 units on a scale Standard Deviation 1.02
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Induration (Lower Limbs)(n=312,321,66,65)	1.24 units on a scale Standard Deviation 1.04	0.96 units on a scale Standard Deviation 1.03	1.52 units on a scale Standard Deviation 0.85	1.66 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Scaling (Head\Neck) (n=312,321,66,65)	0.86 units on a scale Standard Deviation 0.97	0.63 units on a scale Standard Deviation 0.94	0.98 units on a scale Standard Deviation 0.90	1.09 units on a scale Standard Deviation 1.06
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Scaling (Upper Limbs) (n=312,321,66,65)	1.23 units on a scale Standard Deviation 1.00	1.02 units on a scale Standard Deviation 1.03	1.50 units on a scale Standard Deviation 0.88	1.63 units on a scale Standard Deviation 0.94
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Scaling (Trunk) (n=312,321,66,65)	0.99 units on a scale Standard Deviation 0.94	0.76 units on a scale Standard Deviation 1.00	1.20 units on a scale Standard Deviation 1.03	1.49 units on a scale Standard Deviation 1.17
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Erythema (Head\Neck) (n=363,360,66,66)	2.31 units on a scale Standard Deviation 0.99	2.23 units on a scale Standard Deviation 1.01	2.38 units on a scale Standard Deviation 0.99	2.26 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Erythema (Upper Limbs) (n=363,360,66,66)	2.87 units on a scale Standard Deviation 0.64	2.88 units on a scale Standard Deviation 0.64	2.83 units on a scale Standard Deviation 0.54	2.92 units on a scale Standard Deviation 0.54
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Erythema (Trunk) (n=363,360,66,66)	2.85 units on a scale Standard Deviation 0.77	2.91 units on a scale Standard Deviation 0.73	2.79 units on a scale Standard Deviation 0.85	3.08 units on a scale Standard Deviation 0.56
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Erythema (Lower Limbs) (n=363,360,66,66)	3.21 units on a scale Standard Deviation 0.60	3.19 units on a scale Standard Deviation 0.62	3.14 units on a scale Standard Deviation 0.58	3.27 units on a scale Standard Deviation 0.62
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration (Upper Limbs)(n=363,360,66,66)	2.69 units on a scale Standard Deviation 0.71	2.65 units on a scale Standard Deviation 0.67	2.71 units on a scale Standard Deviation 0.58	2.68 units on a scale Standard Deviation 0.59
Psoriasis Area and Severity Index (PASI) Component Scores Week 20: Scaling (Lower Limbs) (n=312,321,66,65)	1.30 units on a scale Standard Deviation 1.04	0.96 units on a scale Standard Deviation 1.03	1.55 units on a scale Standard Deviation 1.00	1.80 units on a scale Standard Deviation 1.18
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Induration (Trunk) (n=363,360,66,66)	2.60 units on a scale Standard Deviation 0.80	2.63 units on a scale Standard Deviation 0.77	2.53 units on a scale Standard Deviation 0.83	2.71 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Erythema (Head\Neck) (n=300,307,61,61)	0.83 units on a scale Standard Deviation 0.99	0.65 units on a scale Standard Deviation 0.93	0.54 units on a scale Standard Deviation 0.81	0.51 units on a scale Standard Deviation 0.87
Psoriasis Area and Severity Index (PASI) Component Scores Baseline:Induration (Lower Limbs)(n=363,360,66,66)	2.91 units on a scale Standard Deviation 0.69	2.90 units on a scale Standard Deviation 0.66	2.83 units on a scale Standard Deviation 0.69	2.98 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Erythema (Upper Limbs) (n=300,307,61,61)	1.20 units on a scale Standard Deviation 1.08	0.96 units on a scale Standard Deviation 1.00	1.16 units on a scale Standard Deviation 0.92	1.05 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Erythema (Trunk) (n=300,307,61,61)	1.09 units on a scale Standard Deviation 1.14	0.77 units on a scale Standard Deviation 1.04	0.92 units on a scale Standard Deviation 0.90	0.95 units on a scale Standard Deviation 0.97
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Erythema (Lower Limbs) (n=300,307,61,61)	1.27 units on a scale Standard Deviation 1.19	0.97 units on a scale Standard Deviation 1.09	1.21 units on a scale Standard Deviation 0.97	1.15 units on a scale Standard Deviation 1.00
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Induration (Head\Neck) (n=300,307,61,61)	0.66 units on a scale Standard Deviation 0.89	0.47 units on a scale Standard Deviation 0.76	0.44 units on a scale Standard Deviation 0.70	0.31 units on a scale Standard Deviation 0.72
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Scaling (Head\Neck) (n=363,360,66,66)	2.32 units on a scale Standard Deviation 1.05	2.23 units on a scale Standard Deviation 1.08	2.33 units on a scale Standard Deviation 1.10	2.24 units on a scale Standard Deviation 1.07
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Induration (Upper Limbs)(n=300,307,61,61)	1.10 units on a scale Standard Deviation 1.05	0.90 units on a scale Standard Deviation 1.01	1.00 units on a scale Standard Deviation 0.84	0.79 units on a scale Standard Deviation 0.82
Psoriasis Area and Severity Index (PASI) Component Scores Baseline: Scaling (Upper Limbs) (n=363,360,66,66)	2.75 units on a scale Standard Deviation 0.78	2.71 units on a scale Standard Deviation 0.75	2.55 units on a scale Standard Deviation 0.59	2.76 units on a scale Standard Deviation 0.70
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Induration (Trunk) (n=300,307,61,61)	0.93 units on a scale Standard Deviation 1.03	0.69 units on a scale Standard Deviation 1.00	0.75 units on a scale Standard Deviation 0.85	0.80 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Induration (Lower Limbs)(n=300,307,61,61)	1.09 units on a scale Standard Deviation 1.08	0.79 units on a scale Standard Deviation 0.99	0.98 units on a scale Standard Deviation 0.83	0.87 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Scaling (Head\Neck) (n=300,307,61,61)	0.77 units on a scale Standard Deviation 0.95	0.57 units on a scale Standard Deviation 0.85	0.56 units on a scale Standard Deviation 0.76	0.44 units on a scale Standard Deviation 0.85
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Scaling (Upper Limbs) (n=300,307,61,61)	1.15 units on a scale Standard Deviation 1.06	0.90 units on a scale Standard Deviation 0.99	1.08 units on a scale Standard Deviation 0.86	0.98 units on a scale Standard Deviation 0.92
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Scaling (Trunk) (n=300,307,61,61)	0.89 units on a scale Standard Deviation 0.97	0.64 units on a scale Standard Deviation 0.90	0.80 units on a scale Standard Deviation 0.87	0.90 units on a scale Standard Deviation 1.14
Psoriasis Area and Severity Index (PASI) Component Scores Week 28: Scaling (Lower Limbs) (n=300,307,61,61)	1.15 units on a scale Standard Deviation 1.07	0.79 units on a scale Standard Deviation 0.99	1.02 units on a scale Standard Deviation 0.90	1.08 units on a scale Standard Deviation 1.08
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Erythema (Head\Neck) (n=203,242,53,47)	0.55 units on a scale Standard Deviation 0.87	0.54 units on a scale Standard Deviation 0.85	0.51 units on a scale Standard Deviation 0.87	0.32 units on a scale Standard Deviation 0.69
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Erythema (Upper Limbs) (n=203,242,53,47)	0.87 units on a scale Standard Deviation 0.97	0.76 units on a scale Standard Deviation 0.92	1.06 units on a scale Standard Deviation 0.93	0.55 units on a scale Standard Deviation 0.90
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Erythema (Trunk) (n=203,242,53,47)	0.68 units on a scale Standard Deviation 0.95	0.52 units on a scale Standard Deviation 0.87	0.68 units on a scale Standard Deviation 0.89	0.57 units on a scale Standard Deviation 0.77
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Erythema (Lower Limbs) (n=203,242,53,47)	0.88 units on a scale Standard Deviation 1.05	0.72 units on a scale Standard Deviation 0.97	0.92 units on a scale Standard Deviation 1.00	0.55 units on a scale Standard Deviation 0.83
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Erythema (Head\Neck) (n=358,358,66,64)	1.84 units on a scale Standard Deviation 1.05	1.72 units on a scale Standard Deviation 1.05	2.14 units on a scale Standard Deviation 0.99	2.17 units on a scale Standard Deviation 0.88
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Induration (Head\Neck) (n=203,242,53,47)	0.44 units on a scale Standard Deviation 0.73	0.45 units on a scale Standard Deviation 0.76	0.43 units on a scale Standard Deviation 0.82	0.23 units on a scale Standard Deviation 0.52
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Induration (Upper Limbs)(n=203,242,53,47)	0.79 units on a scale Standard Deviation 0.93	0.72 units on a scale Standard Deviation 0.87	1.00 units on a scale Standard Deviation 0.88	0.36 units on a scale Standard Deviation 0.67
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Induration (Trunk) (n=203,242,53,47)	0.56 units on a scale Standard Deviation 0.80	0.48 units on a scale Standard Deviation 0.81	0.57 units on a scale Standard Deviation 0.75	0.32 units on a scale Standard Deviation 0.59
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Induration (Lower Limbs)(n=203,242,53,47)	0.70 units on a scale Standard Deviation 0.91	0.62 units on a scale Standard Deviation 0.91	0.85 units on a scale Standard Deviation 0.77	0.32 units on a scale Standard Deviation 0.59
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Scaling (Head\Neck) (n=203,242,53,47)	0.53 units on a scale Standard Deviation 0.82	0.52 units on a scale Standard Deviation 0.90	0.51 units on a scale Standard Deviation 0.78	0.30 units on a scale Standard Deviation 0.59
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Scaling (Upper Limbs) (n=203,242,53,47)	0.85 units on a scale Standard Deviation 0.97	0.71 units on a scale Standard Deviation 0.91	1.06 units on a scale Standard Deviation 0.82	0.49 units on a scale Standard Deviation 0.80
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Scaling (Trunk) (n=203,242,53,47)	0.53 units on a scale Standard Deviation 0.79	0.44 units on a scale Standard Deviation 0.77	0.58 units on a scale Standard Deviation 0.75	0.47 units on a scale Standard Deviation 0.78
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Erythema (Upper Limbs) (n=358,358,66,64)	2.40 units on a scale Standard Deviation 0.80	2.26 units on a scale Standard Deviation 0.86	2.64 units on a scale Standard Deviation 0.62	2.83 units on a scale Standard Deviation 0.68
Psoriasis Area and Severity Index (PASI) Component Scores Week 40: Scaling (Lower Limbs) (n=203,242,53,47)	0.78 units on a scale Standard Deviation 0.97	0.62 units on a scale Standard Deviation 0.90	0.85 units on a scale Standard Deviation 0.86	0.45 units on a scale Standard Deviation 0.75
Psoriasis Area and Severity Index (PASI) Component Scores Week 2: Erythema (Trunk) (n=358,358,66,64)	2.39 units on a scale Standard Deviation 0.92	2.28 units on a scale Standard Deviation 0.89	2.58 units on a scale Standard Deviation 0.88	2.91 units on a scale Standard Deviation 0.73
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Erythema (Head\Neck) (n=180,219,47,46)	0.50 units on a scale Standard Deviation 0.76	0.42 units on a scale Standard Deviation 0.78	0.55 units on a scale Standard Deviation 0.83	0.39 units on a scale Standard Deviation 0.74
Psoriasis Area and Severity Index (PASI) Component Scores Week 52: Erythema (Upper Limbs) (n=180,219,47,46)	0.93 units on a scale Standard Deviation 0.95	0.72 units on a scale Standard Deviation 0.87	1.06 units on a scale Standard Deviation 0.94	0.50 units on a scale Standard Deviation 0.81

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. 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 body surface area (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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 12: Erythema (Trunk) (n=345,345,65,66)	-1.32 units on a scale Standard Deviation 1.22	-1.80 units on a scale Standard Deviation 1.15	-0.43 units on a scale Standard Deviation 1.00	-0.55 units on a scale Standard Deviation 0.83
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=345,345,65,66)	-1.40 units on a scale Standard Deviation 1.17	-1.79 units on a scale Standard Deviation 1.10	-0.60 units on a scale Standard Deviation 0.72	-0.50 units on a scale Standard Deviation 0.79
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=347,350,65,66)	-1.18 units on a scale Standard Deviation 1.10	-1.54 units on a scale Standard Deviation 1.03	-0.52 units on a scale Standard Deviation 0.87	-0.53 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 8: Erythema (Lower Limbs) (n=347,350,65,66)	-1.22 units on a scale Standard Deviation 1.10	-1.48 units on a scale Standard Deviation 1.00	-0.51 units on a scale Standard Deviation 0.73	-0.36 units on a scale Standard Deviation 0.65
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=347,350,65,66)	-1.02 units on a scale Standard Deviation 1.10	-1.21 units on a scale Standard Deviation 1.10	-0.45 units on a scale Standard Deviation 0.87	-0.35 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 8: Induration (Upper Limbs) (n=347,350,65,66)	-1.07 units on a scale Standard Deviation 0.98	-1.26 units on a scale Standard Deviation 0.99	-0.55 units on a scale Standard Deviation 0.75	-0.24 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 8: Induration (Trunk) (n=347,350,65,66)	-1.14 units on a scale Standard Deviation 1.05	-1.36 units on a scale Standard Deviation 1.06	-0.54 units on a scale Standard Deviation 0.89	-0.33 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: Induration (Lower Limbs) (n=347,350,65,66)	-1.16 units on a scale Standard Deviation 1.06	-1.42 units on a scale Standard Deviation 0.99	-0.48 units on a scale Standard Deviation 0.69	-0.32 units on a scale Standard Deviation 0.79
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=347,350,65,66)	-1.12 units on a scale Standard Deviation 1.17	-1.39 units on a scale Standard Deviation 1.16	-0.52 units on a scale Standard Deviation 1.03	-0.36 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: Scaling (Upper Limbs) (n=347,350,65,66)	-1.08 units on a scale Standard Deviation 1.07	-1.33 units on a scale Standard Deviation 1.08	-0.49 units on a scale Standard Deviation 0.77	-0.41 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 8: Scaling (Trunk) (n=347,350,65,66)	-1.18 units on a scale Standard Deviation 1.11	-1.40 units on a scale Standard Deviation 1.12	-0.57 units on a scale Standard Deviation 0.87	-0.58 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 8: Scaling (Lower Limbs) (n=347,350,65,66)	-1.17 units on a scale Standard Deviation 1.11	-1.44 units on a scale Standard Deviation 1.09	-0.55 units on a scale Standard Deviation 0.81	-0.42 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 12: Erythema (Head\Neck) (n=345,345,65,66)	-1.18 units on a scale Standard Deviation 1.21	-1.41 units on a scale Standard Deviation 1.16	-0.58 units on a scale Standard Deviation 1.03	-0.41 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 12: Erythema (Upper Limbs) (n=345,345,65,66)	-1.26 units on a scale Standard Deviation 1.15	-1.61 units on a scale Standard Deviation 1.06	-0.48 units on a scale Standard Deviation 0.79	-0.39 units on a scale Standard Deviation 0.72
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=345,345,65,66)	-1.16 units on a scale Standard Deviation 1.18	-1.32 units on a scale Standard Deviation 1.15	-0.60 units on a scale Standard Deviation 0.97	-0.45 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 12: Induration (Upper Limbs)(n=345,345,65,66)	-1.21 units on a scale Standard Deviation 1.14	-1.47 units on a scale Standard Deviation 1.05	-0.66 units on a scale Standard Deviation 0.78	-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 12: Induration (Trunk) (n=345,345,65,66)	-1.25 units on a scale Standard Deviation 1.17	-1.65 units on a scale Standard Deviation 1.14	-0.63 units on a scale Standard Deviation 0.88	-0.44 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 12: Induration (Lower Limbs)(n=345,345,65,66)	-1.33 units on a scale Standard Deviation 1.18	-1.72 units on a scale Standard Deviation 1.09	-0.57 units on a scale Standard Deviation 0.68	-0.44 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 12: Scaling (Head\Neck) (n=345,345,65,66)	-1.28 units on a scale Standard Deviation 1.20	-1.52 units on a scale Standard Deviation 1.20	-0.57 units on a scale Standard Deviation 1.06	-0.48 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 12: Scaling (Upper Limbs) (n=345,345,65,66)	-1.24 units on a scale Standard Deviation 1.22	-1.52 units on a scale Standard Deviation 1.17	-0.51 units on a scale Standard Deviation 0.95	-0.48 units on a scale Standard Deviation 0.83
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=345,345,65,66)	-1.30 units on a scale Standard Deviation 1.19	-1.65 units on a scale Standard Deviation 1.16	-0.46 units on a scale Standard Deviation 0.90	-0.52 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 (Lower Limbs) (n=345,345,65,66)	-1.41 units on a scale Standard Deviation 1.17	-1.76 units on a scale Standard Deviation 1.13	-0.63 units on a scale Standard Deviation 0.84	-0.44 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 16: Erythema (Head\Neck) (n=323,335,66,66)	-1.28 units on a scale Standard Deviation 1.26	-1.48 units on a scale Standard Deviation 1.19	-0.65 units on a scale Standard Deviation 0.97	-0.35 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 16: Erythema (Upper Limbs) (n=323,335,66,66)	-1.41 units on a scale Standard Deviation 1.19	-1.76 units on a scale Standard Deviation 1.12	-0.53 units on a scale Standard Deviation 0.86	-0.39 units on a scale Standard Deviation 0.74
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=323,335,66,66)	-1.45 units on a scale Standard Deviation 1.23	-1.90 units on a scale Standard Deviation 1.18	-0.65 units on a scale Standard Deviation 1.10	-0.50 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 16: Erythema (Lower Limbs) (n=323,335,66,66)	-1.59 units on a scale Standard Deviation 1.23	-1.94 units on a scale Standard Deviation 1.17	-0.62 units on a scale Standard Deviation 0.84	-0.45 units on a scale Standard Deviation 0.79
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=323,335,66,66)	-1.22 units on a scale Standard Deviation 1.22	-1.37 units on a scale Standard Deviation 1.16	-0.71 units on a scale Standard Deviation 1.00	-0.44 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: Induration (Upper Limbs)(n=323,335,66,66)	-1.35 units on a scale Standard Deviation 1.19	-1.58 units on a scale Standard Deviation 1.14	-0.65 units on a scale Standard Deviation 0.83	-0.35 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 16: Induration (Trunk) (n=323,335,66,66)	-1.37 units on a scale Standard Deviation 1.18	-1.75 units on a scale Standard Deviation 1.21	-0.70 units on a scale Standard Deviation 1.01	-0.42 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 16: Induration (Lower Limbs)(n=323,335,66,66)	-1.54 units on a scale Standard Deviation 1.22	-1.88 units on a scale Standard Deviation 1.19	-0.64 units on a scale Standard Deviation 0.76	-0.47 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 16: Scaling (Head\Neck) (n=323,335,66,66)	-1.37 units on a scale Standard Deviation 1.26	-1.57 units on a scale Standard Deviation 1.24	-0.74 units on a scale Standard Deviation 1.06	-0.48 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 16: Scaling (Upper Limbs) (n=323,335,66,66)	-1.35 units on a scale Standard Deviation 1.22	-1.63 units on a scale Standard Deviation 1.20	-0.47 units on a scale Standard Deviation 0.88	-0.47 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 16: Scaling (Trunk) (n=323,335,66,66)	-1.44 units on a scale Standard Deviation 1.16	-1.76 units on a scale Standard Deviation 1.17	-0.53 units on a scale Standard Deviation 1.00	-0.65 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: Scaling (Lower Limbs) (n=323,335,66,66)	-1.56 units on a scale Standard Deviation 1.17	-1.89 units on a scale Standard Deviation 1.22	-0.62 units on a scale Standard Deviation 0.91	-0.47 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 20: Erythema (Head\Neck) (n=312,321,66,65)	-1.37 units on a scale Standard Deviation 1.20	-1.57 units on a scale Standard Deviation 1.25	-1.30 units on a scale Standard Deviation 0.99	-1.02 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 20: Erythema (Upper Limbs) (n=312,321,66,65)	-1.58 units on a scale Standard Deviation 1.18	-1.84 units on a scale Standard Deviation 1.13	-1.35 units on a scale Standard Deviation 0.92	-1.12 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 (Trunk) (n=312,321,66,65)	-1.63 units on a scale Standard Deviation 1.20	-2.03 units on a scale Standard Deviation 1.16	-1.42 units on a scale Standard Deviation 1.02	-1.40 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=312,321,66,65)	-1.77 units on a scale Standard Deviation 1.20	-2.06 units on a scale Standard Deviation 1.18	-1.42 units on a scale Standard Deviation 0.82	-1.34 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 20: Induration (Head\Neck) (n=312,321,66,65)	-1.29 units on a scale Standard Deviation 1.20	-1.44 units on a scale Standard Deviation 1.18	-1.30 units on a scale Standard Deviation 0.96	-1.03 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 20: Induration (Upper Limbs)(n=312,321,66,65)	-1.48 units on a scale Standard Deviation 1.18	-1.65 units on a scale Standard Deviation 1.13	-1.33 units on a scale Standard Deviation 0.79	-1.15 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: Induration (Trunk) (n=312,321,66,65)	-1.53 units on a scale Standard Deviation 1.16	-1.83 units on a scale Standard Deviation 1.21	-1.36 units on a scale Standard Deviation 1.00	-1.28 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 20: Induration (Lower Limbs)(n=312,321,66,65)	-1.68 units on a scale Standard Deviation 1.22	-1.93 units on a scale Standard Deviation 1.21	-1.32 units on a scale Standard Deviation 0.95	-1.32 units on a scale Standard Deviation 1.05
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=312,321,66,65)	-1.47 units on a scale Standard Deviation 1.21	-1.63 units on a scale Standard Deviation 1.26	-1.35 units on a scale Standard Deviation 1.17	-1.15 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 20: Scaling (Upper Limbs) (n=312,321,66,65)	-1.52 units on a scale Standard Deviation 1.18	-1.69 units on a scale Standard Deviation 1.21	-1.05 units on a scale Standard Deviation 1.01	-1.14 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 20: Scaling (Trunk) (n=312,321,66,65)	-1.60 units on a scale Standard Deviation 1.12	-1.84 units on a scale Standard Deviation 1.20	-1.17 units on a scale Standard Deviation 1.02	-1.28 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 20: Scaling (Lower Limbs) (n=312,321,66,65)	-1.68 units on a scale Standard Deviation 1.19	-1.94 units on a scale Standard Deviation 1.23	-1.23 units on a scale Standard Deviation 1.11	-1.18 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: Erythema (Head\Neck) (n=300,307,61,61)	-1.47 units on a scale Standard Deviation 1.24	-1.59 units on a scale Standard Deviation 1.23	-1.80 units on a scale Standard Deviation 1.08	-1.70 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 28: Erythema (Upper Limbs) (n=300,307,61,61)	-1.67 units on a scale Standard Deviation 1.24	-1.92 units on a scale Standard Deviation 1.13	-1.67 units on a scale Standard Deviation 1.04	-1.89 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: Erythema (Trunk) (n=300,307,61,61)	-1.77 units on a scale Standard Deviation 1.29	-2.15 units on a scale Standard Deviation 1.17	-1.89 units on a scale Standard Deviation 0.98	-2.13 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 28: Erythema (Lower Limbs) (n=300,307,61,61)	-1.95 units on a scale Standard Deviation 1.22	-2.23 units on a scale Standard Deviation 1.22	-1.92 units on a scale Standard Deviation 0.99	-2.11 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 28: Induration (Head\Neck) (n=300,307,61,61)	-1.40 units on a scale Standard Deviation 1.20	-1.53 units on a scale Standard Deviation 1.16	-1.69 units on a scale Standard Deviation 1.13	-1.64 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 28: Induration (Upper Limbs)(n=300,307,61,61)	-1.58 units on a scale Standard Deviation 1.23	-1.75 units on a scale Standard Deviation 1.13	-1.70 units on a scale Standard Deviation 0.95	-1.92 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 28: Induration (Trunk) (n=300,307,61,61)	-1.66 units on a scale Standard Deviation 1.19	-1.92 units on a scale Standard Deviation 1.21	-1.80 units on a scale Standard Deviation 1.01	-1.93 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 (Lower Limbs)(n=300,307,61,61)	-1.81 units on a scale Standard Deviation 1.27	-2.11 units on a scale Standard Deviation 1.21	-1.89 units on a scale Standard Deviation 1.00	-2.11 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 28: Scaling (Head\Neck) (n=300,307,61,61)	-1.55 units on a scale Standard Deviation 1.28	-1.71 units on a scale Standard Deviation 1.23	-1.72 units on a scale Standard Deviation 1.29	-1.79 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: Scaling (Upper Limbs) (n=300,307,61,61)	-1.59 units on a scale Standard Deviation 1.28	-1.81 units on a scale Standard Deviation 1.22	-1.48 units on a scale Standard Deviation 1.03	-1.84 units on a scale Standard Deviation 1.07
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=300,307,61,61)	-1.72 units on a scale Standard Deviation 1.23	-1.97 units on a scale Standard Deviation 1.14	-1.61 units on a scale Standard Deviation 1.07	-1.90 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: Scaling (Lower Limbs) (n=300,307,61,61)	-1.81 units on a scale Standard Deviation 1.24	-2.12 units on a scale Standard Deviation 1.21	-1.80 units on a scale Standard Deviation 1.09	-1.95 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: Erythema (Head\Neck) (n=203,242,53,47)	-1.78 units on a scale Standard Deviation 1.15	-1.69 units on a scale Standard Deviation 1.16	-1.83 units on a scale Standard Deviation 1.14	-1.81 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 (Upper Limbs) (n=203,242,53,47)	-2.02 units on a scale Standard Deviation 1.15	-2.11 units on a scale Standard Deviation 1.09	-1.75 units on a scale Standard Deviation 1.12	-2.40 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 40: Erythema (Trunk) (n=203,242,53,47)	-2.19 units on a scale Standard Deviation 1.14	-2.40 units on a scale Standard Deviation 1.03	-2.11 units on a scale Standard Deviation 0.95	-2.45 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 40: Erythema (Lower Limbs) (n=203,242,53,47)	-2.34 units on a scale Standard Deviation 1.10	-2.45 units on a scale Standard Deviation 1.11	-2.21 units on a scale Standard Deviation 1.10	-2.68 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 40: Induration (Head\Neck) (n=203,242,53,47)	-1.68 units on a scale Standard Deviation 1.10	-1.56 units on a scale Standard Deviation 1.14	-1.72 units on a scale Standard Deviation 1.26	-1.72 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 40: Induration (Upper Limbs)(n=203,242,53,47)	-1.94 units on a scale Standard Deviation 1.09	-1.93 units on a scale Standard Deviation 1.04	-1.70 units on a scale Standard Deviation 1.01	-2.32 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 40: Induration (Trunk) (n=203,242,53,47)	-2.09 units on a scale Standard Deviation 1.02	-2.15 units on a scale Standard Deviation 1.10	-2.00 units on a scale Standard Deviation 0.98	-2.30 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: Induration (Lower Limbs)(n=203,242,53,47)	-2.29 units on a scale Standard Deviation 1.10	-2.28 units on a scale Standard Deviation 1.15	-2.04 units on a scale Standard Deviation 1.00	-2.64 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 40: Scaling (Head\Neck) (n=203,242,53,47)	-1.85 units on a scale Standard Deviation 1.18	-1.77 units on a scale Standard Deviation 1.27	-1.87 units on a scale Standard Deviation 1.35	-1.96 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 40: Scaling (Upper Limbs) (n=203,242,53,47)	-1.95 units on a scale Standard Deviation 1.22	-2.01 units on a scale Standard Deviation 1.19	-1.55 units on a scale Standard Deviation 0.99	-2.34 units on a scale Standard Deviation 1.05
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=203,242,53,47)	-2.15 units on a scale Standard Deviation 1.07	-2.20 units on a scale Standard Deviation 1.07	-1.81 units on a scale Standard Deviation 1.06	-2.26 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 40: Scaling (Lower Limbs) (n=203,242,53,47)	-2.20 units on a scale Standard Deviation 1.16	-2.30 units on a scale Standard Deviation 1.19	-2.00 units on a scale Standard Deviation 1.09	-2.57 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 52: Erythema (Head\Neck) (n=180,219,47,46)	-1.81 units on a scale Standard Deviation 1.08	-1.75 units on a scale Standard Deviation 1.18	-1.70 units on a scale Standard Deviation 1.20	-1.74 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 52: Erythema (Upper Limbs) (n=180,219,47,46)	-1.95 units on a scale Standard Deviation 1.13	-2.13 units on a scale Standard Deviation 1.04	-1.77 units on a scale Standard Deviation 1.16	-2.46 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 52: Erythema (Trunk) (n=180,219,47,46)	-2.22 units on a scale Standard Deviation 1.12	-2.31 units on a scale Standard Deviation 1.13	-2.15 units on a scale Standard Deviation 1.02	-2.52 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 52: Erythema (Lower Limbs) (n=180,219,47,46)	-2.29 units on a scale Standard Deviation 1.16	-2.50 units on a scale Standard Deviation 1.12	-2.26 units on a scale Standard Deviation 1.13	-2.61 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 52: Induration (Head\Neck) (n=180,219,47,46)	-1.65 units on a scale Standard Deviation 1.11	-1.69 units on a scale Standard Deviation 1.13	-1.68 units on a scale Standard Deviation 1.09	-1.72 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 52: Induration (Upper Limbs)(n=180,219,47,46)	-1.86 units on a scale Standard Deviation 1.12	-1.95 units on a scale Standard Deviation 1.07	-1.70 units on a scale Standard Deviation 1.04	-2.24 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 52: Induration (Trunk) (n=180,219,47,46)	-2.08 units on a scale Standard Deviation 1.03	-2.11 units on a scale Standard Deviation 1.16	-2.04 units on a scale Standard Deviation 1.04	-2.24 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 52: Induration (Lower Limbs)(n=180,219,47,46)	-2.17 units on a scale Standard Deviation 1.17	-2.30 units on a scale Standard Deviation 1.18	-2.13 units on a scale Standard Deviation 1.10	-2.54 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 52: Scaling (Head\Neck) (n=180,219,47,46)	-1.86 units on a scale Standard Deviation 1.16	-1.87 units on a scale Standard Deviation 1.23	-1.68 units on a scale Standard Deviation 1.29	-1.89 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 (Upper Limbs) (n=180,219,47,46)	-1.87 units on a scale Standard Deviation 1.20	-1.99 units on a scale Standard Deviation 1.11	-1.53 units on a scale Standard Deviation 1.10	-2.26 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 52: Scaling (Trunk) (n=180,219,47,46)	-2.17 units on a scale Standard Deviation 1.05	-2.16 units on a scale Standard Deviation 1.08	-1.85 units on a scale Standard Deviation 1.12	-2.28 units on a scale Standard Deviation 1.07
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=180,219,47,46)	-2.12 units on a scale Standard Deviation 1.16	-2.35 units on a scale Standard Deviation 1.16	-1.98 units on a scale Standard Deviation 1.24	-2.52 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 (Head\Neck) (n=358,358,66,64)	-0.45 units on a scale Standard Deviation 0.78	-0.51 units on a scale Standard Deviation 0.82	-0.24 units on a scale Standard Deviation 0.61	-0.06 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 2: Erythema (Upper Limbs) (n=358,358,66,64)	-0.46 units on a scale Standard Deviation 0.68	-0.63 units on a scale Standard Deviation 0.71	-0.20 units on a scale Standard Deviation 0.47	-0.09 units on a scale Standard Deviation 0.56
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=358,358,66,64)	-0.46 units on a scale Standard Deviation 0.69	-0.63 units on a scale Standard Deviation 0.74	-0.21 units on a scale Standard Deviation 0.51	-0.17 units on a scale Standard Deviation 0.49
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=358,358,66,64)	-0.47 units on a scale Standard Deviation 0.70	-0.59 units on a scale Standard Deviation 0.74	-0.15 units on a scale Standard Deviation 0.44	-0.13 units on a scale Standard Deviation 0.58
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=358,358,66,64)	-0.37 units on a scale Standard Deviation 0.67	-0.48 units on a scale Standard Deviation 0.78	-0.20 units on a scale Standard Deviation 0.53	-0.08 units on a scale Standard Deviation 0.57
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=358,358,66,64)	-0.42 units on a scale Standard Deviation 0.67	-0.53 units on a scale Standard Deviation 0.74	-0.35 units on a scale Standard Deviation 0.62	-0.11 units on a scale Standard Deviation 0.54
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=358,358,66,64)	-0.40 units on a scale Standard Deviation 0.72	-0.53 units on a scale Standard Deviation 0.74	-0.21 units on a scale Standard Deviation 0.48	-0.14 units on a scale Standard Deviation 0.50
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=358,358,66,64)	-0.41 units on a scale Standard Deviation 0.66	-0.52 units on a scale Standard Deviation 0.65	-0.21 units on a scale Standard Deviation 0.45	-0.27 units on a scale Standard Deviation 0.48
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=358,358,66,64)	-0.47 units on a scale Standard Deviation 0.67	-0.56 units on a scale Standard Deviation 0.86	-0.30 units on a scale Standard Deviation 0.80	-0.17 units on a scale Standard Deviation 0.55
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=358,358,66,64)	-0.45 units on a scale Standard Deviation 0.72	-0.63 units on a scale Standard Deviation 0.81	-0.29 units on a scale Standard Deviation 0.55	-0.20 units on a scale Standard Deviation 0.72
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=358,358,66,64)	-0.48 units on a scale Standard Deviation 0.75	-0.60 units on a scale Standard Deviation 0.81	-0.23 units on a scale Standard Deviation 0.70	-0.30 units on a scale Standard Deviation 0.61
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=358,358,66,64)	-0.48 units on a scale Standard Deviation 0.74	-0.57 units on a scale Standard Deviation 0.74	-0.24 units on a scale Standard Deviation 0.66	-0.23 units on a scale Standard Deviation 0.61
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=352,350,65,66)	-0.84 units on a scale Standard Deviation 1.04	-0.90 units on a scale Standard Deviation 1.01	-0.48 units on a scale Standard Deviation 0.87	-0.33 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 4: Erythema (Upper Limbs) (n=352,350,65,66)	-0.86 units on a scale Standard Deviation 0.88	-1.03 units on a scale Standard Deviation 0.84	-0.42 units on a scale Standard Deviation 0.73	-0.20 units on a scale Standard Deviation 0.64
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=352,350,65,66)	-0.86 units on a scale Standard Deviation 0.88	-1.08 units on a scale Standard Deviation 0.95	-0.37 units on a scale Standard Deviation 0.86	-0.33 units on a scale Standard Deviation 0.59
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=352,350,65,66)	-0.86 units on a scale Standard Deviation 0.89	-1.04 units on a scale Standard Deviation 0.87	-0.35 units on a scale Standard Deviation 0.62	-0.30 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 4: Induration (Head\Neck) (n=352,350,65,66)	-0.79 units on a scale Standard Deviation 0.97	-0.85 units on a scale Standard Deviation 1.00	-0.40 units on a scale Standard Deviation 0.68	-0.27 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 4: Induration (Upper Limbs) (n=352,350,65,66)	-0.82 units on a scale Standard Deviation 0.88	-0.91 units on a scale Standard Deviation 0.85	-0.46 units on a scale Standard Deviation 0.69	-0.15 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: Induration (Trunk) (n=352,350,65,66)	-0.79 units on a scale Standard Deviation 0.89	-0.95 units on a scale Standard Deviation 0.90	-0.37 units on a scale Standard Deviation 0.88	-0.18 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: Induration (Lower Limbs) (n=352,350,65,66)	-0.85 units on a scale Standard Deviation 0.85	-0.96 units on a scale Standard Deviation 0.82	-0.35 units on a scale Standard Deviation 0.60	-0.27 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: Scaling (Head\Neck) (n=352,350,65,66)	-0.88 units on a scale Standard Deviation 1.00	-0.99 units on a scale Standard Deviation 1.07	-0.54 units on a scale Standard Deviation 0.95	-0.30 units on a scale Standard Deviation 0.74
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=352,350,65,66)	-0.86 units on a scale Standard Deviation 0.97	-1.00 units on a scale Standard Deviation 0.93	-0.40 units on a scale Standard Deviation 0.72	-0.33 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 4: Scaling (Trunk) (n=352,350,65,66)	-0.81 units on a scale Standard Deviation 0.93	-1.03 units on a scale Standard Deviation 0.96	-0.37 units on a scale Standard Deviation 0.84	-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 4: Scaling (Lower Limbs) (n=352,350,65,66)	-0.87 units on a scale Standard Deviation 0.96	-0.97 units on a scale Standard Deviation 0.94	-0.45 units on a scale Standard Deviation 0.73	-0.33 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: Erythema (Head\Neck) (n=347,350,65,66)	-1.05 units on a scale Standard Deviation 1.16	-1.28 units on a scale Standard Deviation 1.11	-0.45 units on a scale Standard Deviation 1.03	-0.39 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 8: Erythema (Upper Limbs) (n=347,350,65,66)	-1.10 units on a scale Standard Deviation 1.04	-1.41 units on a scale Standard Deviation 0.99	-0.40 units on a scale Standard Deviation 0.70	-0.32 units on a scale Standard Deviation 0.73

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. Here 'N' (number of participants analyzed) 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.

Outcome measures

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 28	-68.62 percent change Standard Error 1.69	-78.91 percent change Standard Error 1.67	-73.49 percent change Standard Error 3.75	-76.64 percent change Standard Error 3.78
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	-18.50 percent change Standard Error 1.11	-24.86 percent change Standard Error 1.11	-8.99 percent change Standard Error 2.59	-5.85 percent change Standard Error 2.61
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	-34.60 percent change Standard Error 1.45	-43.08 percent change Standard Error 1.46	-15.75 percent change Standard Error 3.38	-10.76 percent change Standard Error 3.38
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	-47.72 percent change Standard Error 1.68	-60.48 percent change Standard Error 1.68	-20.27 percent change Standard Error 3.89	-13.02 percent change Standard Error 3.88
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	-54.07 percent change Standard Error 1.83	-69.11 percent change Standard Error 1.83	-23.02 percent change Standard Error 4.21	-15.26 percent change Standard Error 4.21
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	-57.25 percent change Standard Error 1.97	-72.71 percent change Standard Error 1.96	-25.66 percent change Standard Error 4.51	-13.33 percent change Standard Error 4.51
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	-63.73 percent change Standard Error 1.74	-75.05 percent change Standard Error 1.73	-56.71 percent change Standard Error 3.93	-49.48 percent change Standard Error 3.94
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	-67.06 percent change Standard Error 1.82	-76.36 percent change Standard Error 1.77	-73.52 percent change Standard Error 3.93	-81.21 percent change Standard Error 4.01
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	-64.15 percent change Standard Error 1.91	-74.61 percent change Standard Error 1.85	-70.60 percent change Standard Error 4.11	-80.94 percent change Standard Error 4.17

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. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 52 (n = 180, 219, 47, 46)	4.42 percentage of BSA Standard Deviation 6.93	2.94 percentage of BSA Standard Deviation 5.29	3.79 percentage of BSA Standard Deviation 4.37	2.09 percentage of BSA Standard Deviation 2.80
Total Body Surface Area (BSA) With Psoriasis Baseline (n = 363, 360, 66, 66)	28.48 percentage of BSA Standard Deviation 16.42	31.13 percentage of BSA Standard Deviation 17.64	28.03 percentage of BSA Standard Deviation 16.99	30.17 percentage of BSA Standard Deviation 16.34
Total Body Surface Area (BSA) With Psoriasis Week 2 (n = 358, 358, 66, 64)	27.08 percentage of BSA Standard Deviation 16.85	27.86 percentage of BSA Standard Deviation 17.24	28.21 percentage of BSA Standard Deviation 19.27	30.32 percentage of BSA Standard Deviation 16.99
Total Body Surface Area (BSA) With Psoriasis Week 4 (n = 352, 350, 65, 66)	23.69 percentage of BSA Standard Deviation 16.56	22.79 percentage of BSA Standard Deviation 17.52	27.15 percentage of BSA Standard Deviation 20.08	29.52 percentage of BSA Standard Deviation 17.01
Total Body Surface Area (BSA) With Psoriasis Week 8 (n = 347, 350, 65, 66)	18.99 percentage of BSA Standard Deviation 16.28	16.49 percentage of BSA Standard Deviation 16.23	26.82 percentage of BSA Standard Deviation 19.93	29.43 percentage of BSA Standard Deviation 17.45
Total Body Surface Area (BSA) With Psoriasis Week 12 (n = 345, 345, 65, 66)	15.73 percentage of BSA Standard Deviation 16.03	12.64 percentage of BSA Standard Deviation 15.01	25.89 percentage of BSA Standard Deviation 20.50	29.02 percentage of BSA Standard Deviation 17.58
Total Body Surface Area (BSA) With Psoriasis Week 16 (n = 323, 335, 66, 66)	13.08 percentage of BSA Standard Deviation 15.75	9.48 percentage of BSA Standard Deviation 12.99	25.89 percentage of BSA Standard Deviation 21.77	29.14 percentage of BSA Standard Deviation 19.18
Total Body Surface Area (BSA) With Psoriasis Week 20 (n = 312, 321, 66, 65)	10.77 percentage of BSA Standard Deviation 14.23	7.59 percentage of BSA Standard Deviation 11.45	18.57 percentage of BSA Standard Deviation 20.49	21.73 percentage of BSA Standard Deviation 17.48
Total Body Surface Area (BSA) With Psoriasis Week 28 (n = 300, 307, 61, 61)	8.92 percentage of BSA Standard Deviation 13.07	6.05 percentage of BSA Standard Deviation 9.36	9.54 percentage of BSA Standard Deviation 15.85	9.96 percentage of BSA Standard Deviation 12.39
Total Body Surface Area (BSA) With Psoriasis Week 40 (n = 203, 242, 53, 47)	4.37 percentage of BSA Standard Deviation 7.58	3.51 percentage of BSA Standard Deviation 6.03	4.47 percentage of BSA Standard Deviation 6.96	3.02 percentage of BSA Standard Deviation 4.19

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. 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

Measure	CP-690,550 5 mg n=359 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=358 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 16	-51.87 percent change Standard Error 2.41	-67.12 percent change Standard Error 2.41	-11.22 percent change Standard Error 5.50	2.03 percent change Standard Error 5.50
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 2	-6.89 percent change Standard Error 0.97	-10.44 percent change Standard Error 0.97	-1.92 percent change Standard Error 2.25	-1.23 percent change Standard Error 2.27
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	-18.31 percent change Standard Error 1.58	-26.73 percent change Standard Error 1.58	-5.29 percent change Standard Error 3.67	-1.81 percent change Standard Error 3.66
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	-34.86 percent change Standard Error 1.93	-46.27 percent change Standard Error 1.93	-6.73 percent change Standard Error 4.46	-1.57 percent change Standard Error 4.45
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	-45.72 percent change Standard Error 2.13	-59.20 percent change Standard Error 2.13	-9.62 percent change Standard Error 4.91	-0.84 percent change Standard Error 4.91
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	-58.67 percent change Standard Error 2.22	-71.96 percent change Standard Error 2.21	-37.66 percent change Standard Error 5.03	-26.49 percent change Standard Error 5.04
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	-64.74 percent change Standard Error 2.27	-76.82 percent change Standard Error 2.24	-66.75 percent change Standard Error 5.03	-64.11 percent change Standard Error 5.07
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 40	-73.29 percent change Standard Error 1.72	-80.78 percent change Standard Error 1.67	-73.67 percent change Standard Error 3.69	-79.92 percent change Standard Error 3.78
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	-74.95 percent change Standard Error 1.55	-82.36 percent change Standard Error 1.48	-74.84 percent change Standard Error 3.26	-84.79 percent change Standard Error 3.33

SECONDARY outcome

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

Population: FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). 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. NRI method was used to impute missing values.

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. Percentage of participants with PASI 50 response is reported.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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	9.09 percentage of participants Interval 6.13 to 12.05	17.22 percentage of participants Interval 13.32 to 21.12	3.03 percentage of participants Interval 0.0 to 7.17	0.00 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 4	28.65 percentage of participants Interval 24.0 to 33.3	39.72 percentage of participants Interval 34.67 to 44.78	9.09 percentage of participants Interval 2.16 to 16.03	1.52 percentage of participants Interval 0.0 to 4.46
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 8	47.93 percentage of participants Interval 42.79 to 53.07	65.56 percentage of participants Interval 60.65 to 70.46	18.18 percentage of participants Interval 8.88 to 27.49	12.12 percentage of participants Interval 4.25 to 20.0
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 12	58.95 percentage of participants Interval 53.89 to 64.01	73.89 percentage of participants Interval 69.35 to 78.43	24.24 percentage of participants Interval 13.9 to 34.58	12.12 percentage of participants Interval 4.25 to 20.0
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 16	60.33 percentage of participants Interval 55.3 to 65.36	76.94 percentage of participants Interval 72.59 to 81.3	22.73 percentage of participants Interval 12.62 to 32.84	21.21 percentage of participants Interval 11.35 to 31.08
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 20	66.12 percentage of participants Interval 61.25 to 70.98	75.83 percentage of participants Interval 71.41 to 80.26	63.64 percentage of participants Interval 52.03 to 75.24	54.55 percentage of participants Interval 42.53 to 66.56
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 28	66.39 percentage of participants Interval 61.53 to 71.25	76.11 percentage of participants Interval 71.71 to 80.52	77.27 percentage of participants Interval 67.16 to 87.38	83.33 percentage of participants Interval 74.34 to 92.32
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 40	53.99 percentage of participants Interval 48.87 to 59.12	63.61 percentage of participants Interval 58.64 to 68.58	75.76 percentage of participants Interval 65.42 to 86.1	71.21 percentage of participants Interval 60.29 to 82.14
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response Week 52	48.21 percentage of participants Interval 43.07 to 53.35	59.44 percentage of participants Interval 54.37 to 64.52	66.67 percentage of participants Interval 55.29 to 78.04	69.70 percentage of participants Interval 58.61 to 80.78

SECONDARY outcome

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

Population: FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). 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. NRI method was used to impute missing values.

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 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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	0.28 percentage of participants Interval 0.0 to 0.81	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
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 4	1.65 percentage of participants Interval 0.34 to 2.96	3.89 percentage of participants Interval 1.89 to 5.89	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	9.64 percentage of participants Interval 6.61 to 12.68	18.61 percentage of participants Interval 14.59 to 22.63	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 12	15.43 percentage of participants Interval 11.71 to 19.14	28.06 percentage of participants Interval 23.41 to 32.7	1.52 percentage of participants Interval 0.0 to 4.46	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 16	19.83 percentage of participants Interval 15.73 to 23.94	39.44 percentage of participants Interval 34.4 to 44.49	0.00 percentage of participants Interval 0.0 to 0.0	1.52 percentage of participants Interval 0.0 to 4.46
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 20	23.14 percentage of participants Interval 18.8 to 27.48	40.28 percentage of participants Interval 35.21 to 45.34	7.58 percentage of participants Interval 1.19 to 13.96	9.09 percentage of participants Interval 2.16 to 16.03
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 28	31.13 percentage of participants Interval 26.37 to 35.89	43.61 percentage of participants Interval 38.49 to 48.73	25.76 percentage of participants Interval 15.21 to 36.31	39.39 percentage of participants Interval 27.61 to 51.18
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 40	28.10 percentage of participants Interval 23.48 to 32.72	41.39 percentage of participants Interval 36.3 to 46.48	34.85 percentage of participants Interval 23.35 to 46.34	54.55 percentage of participants Interval 42.53 to 66.56
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response Week 52	23.42 percentage of participants Interval 19.06 to 27.77	36.94 percentage of participants Interval 31.96 to 41.93	31.82 percentage of participants Interval 20.58 to 43.06	53.03 percentage of participants Interval 40.99 to 65.07

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. 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 "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. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 = 358, 358, 66, 64)	0.56 percentage of participants Interval 0.0 to 1.33	1.12 percentage of participants Interval 0.03 to 2.21	4.55 percentage of participants Interval 0.0 to 9.57	3.13 percentage of participants Interval 0.0 to 7.39
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 4 (n = 352, 350, 65, 66)	1.14 percentage of participants Interval 0.03 to 2.24	0.57 percentage of participants Interval 0.0 to 1.36	1.54 percentage of participants Interval 0.0 to 4.53	4.55 percentage of participants Interval 0.0 to 9.57
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 8 (n = 347, 350, 65, 66)	2.02 percentage of participants Interval 0.54 to 3.5	0.29 percentage of participants Interval 0.0 to 0.84	3.08 percentage of participants Interval 0.0 to 7.28	7.58 percentage of participants Interval 1.19 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 = 345, 345, 65, 66)	2.90 percentage of participants Interval 1.13 to 4.67	1.16 percentage of participants Interval 0.03 to 2.29	6.15 percentage of participants Interval 0.31 to 12.0	9.09 percentage of participants Interval 2.16 to 16.03
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 16 (n = 323, 335, 66, 66)	2.48 percentage of participants Interval 0.78 to 4.17	0.90 percentage of participants Interval 0.0 to 1.9	6.06 percentage of participants Interval 0.3 to 11.82	12.12 percentage of participants Interval 4.25 to 20.0
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 20 (n = 312, 321, 66, 65)	1.60 percentage of participants Interval 0.21 to 3.0	0.62 percentage of participants Interval 0.0 to 1.48	1.52 percentage of participants Interval 0.0 to 4.46	4.62 percentage of participants Interval 0.0 to 9.72
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 28 (n = 300, 307, 61, 61)	1.00 percentage of participants Interval 0.0 to 2.13	0.33 percentage of participants Interval 0.0 to 0.96	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 (PASI) Score of at Least 125% of Baseline PASI Score Week 40 (n = 203, 242, 53, 47)	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
Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score Week 52 (n = 180, 219, 47, 46)	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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively.

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

Measure	CP-690,550 5 mg n=247 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=250 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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=247,250,34,46)	26.64 units on a scale Standard Deviation 20.65	28.24 units on a scale Standard Deviation 20.89	26.76 units on a scale Standard Deviation 18.33	23.91 units on a scale Standard Deviation 16.21
Nail Psoriasis Severity Index (NAPSI) Score Week 8 (n=236,242,33,46)	24.32 units on a scale Standard Deviation 20.60	22.47 units on a scale Standard Deviation 19.43	25.55 units on a scale Standard Deviation 18.50	24.61 units on a scale Standard Deviation 16.76
Nail Psoriasis Severity Index (NAPSI) Score Week 16 (n=215,233,34,46)	20.09 units on a scale Standard Deviation 18.79	16.53 units on a scale Standard Deviation 17.87	27.82 units on a scale Standard Deviation 17.64	25.46 units on a scale Standard Deviation 18.57
Nail Psoriasis Severity Index (NAPSI) Score Week 20 (n=210,227,34,45)	16.53 units on a scale Standard Deviation 17.35	12.96 units on a scale Standard Deviation 16.11	23.97 units on a scale Standard Deviation 18.18	21.18 units on a scale Standard Deviation 18.69
Nail Psoriasis Severity Index (NAPSI) Score Week 28 (n=202,213,30,44)	13.42 units on a scale Standard Deviation 16.17	9.49 units on a scale Standard Deviation 13.92	16.77 units on a scale Standard Deviation 14.69	14.77 units on a scale Standard Deviation 17.29
Nail Psoriasis Severity Index (NAPSI) Score Week 40 (n=125,167,24,33)	7.36 units on a scale Standard Deviation 10.04	7.19 units on a scale Standard Deviation 12.71	5.67 units on a scale Standard Deviation 7.92	8.85 units on a scale Standard Deviation 11.27
Nail Psoriasis Severity Index (NAPSI) Score Week 52 (n=110,148,21,32)	6.94 units on a scale Standard Deviation 9.48	6.73 units on a scale Standard Deviation 12.44	5.90 units on a scale Standard Deviation 8.92	6.66 units on a scale Standard Deviation 9.09

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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively.

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

Measure	CP-690,550 5 mg n=247 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=250 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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= 236, 242, 33, 46)	-2.58 units on a scale Standard Deviation 10.98	-5.55 units on a scale Standard Deviation 12.64	-0.82 units on a scale Standard Deviation 7.26	0.70 units on a scale Standard Deviation 6.89
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 16 (n= 215, 233, 34, 46)	-6.91 units on a scale Standard Deviation 13.93	-11.70 units on a scale Standard Deviation 16.68	1.06 units on a scale Standard Deviation 9.37	1.54 units on a scale Standard Deviation 11.34
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 20 (n= 210, 227, 34, 45)	-10.51 units on a scale Standard Deviation 15.17	-15.16 units on a scale Standard Deviation 17.51	-2.79 units on a scale Standard Deviation 11.83	-2.53 units on a scale Standard Deviation 13.00
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 28 (n= 202, 213, 30, 44)	-13.08 units on a scale Standard Deviation 16.53	-19.07 units on a scale Standard Deviation 18.62	-10.30 units on a scale Standard Deviation 13.90	-8.50 units on a scale Standard Deviation 14.18
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 40 (n= 125, 167, 24, 33)	-18.40 units on a scale Standard Deviation 17.47	-21.63 units on a scale Standard Deviation 19.61	-16.38 units on a scale Standard Deviation 15.34	-13.21 units on a scale Standard Deviation 13.07
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Change at Week 52 (n= 110, 148, 21, 32)	-18.49 units on a scale Standard Deviation 17.03	-22.28 units on a scale Standard Deviation 20.33	-17.19 units on a scale Standard Deviation 14.32	-15.97 units on a scale Standard Deviation 12.47

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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively.

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 psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.

Outcome measures

Measure	CP-690,550 5 mg n=247 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=250 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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 Week 40 (n= 125, 167, 24, 33)	3.49 nails Standard Deviation 3.68	2.91 nails Standard Deviation 3.61	3.13 nails Standard Deviation 3.69	3.94 nails Standard Deviation 4.00
Number of Affected Nails Baseline (n= 247, 250, 34, 46)	7.21 nails Standard Deviation 3.14	7.71 nails Standard Deviation 3.12	7.73 nails Standard Deviation 3.05	7.24 nails Standard Deviation 3.39
Number of Affected Nails Week 8 (n= 234, 242, 32, 46)	6.87 nails Standard Deviation 3.58	6.65 nails Standard Deviation 3.80	8.00 nails Standard Deviation 3.01	7.48 nails Standard Deviation 3.00
Number of Affected Nails Week 16 (n= 215, 233, 33, 45)	6.25 nails Standard Deviation 3.79	5.44 nails Standard Deviation 4.16	8.27 nails Standard Deviation 2.65	7.56 nails Standard Deviation 3.03
Number of Affected Nails Week 20 (n= 209, 227, 33, 44)	5.53 nails Standard Deviation 3.83	4.65 nails Standard Deviation 4.13	7.48 nails Standard Deviation 3.01	6.43 nails Standard Deviation 3.70
Number of Affected Nails Week 28 (n= 202, 213, 30, 44)	4.77 nails Standard Deviation 3.92	3.76 nails Standard Deviation 4.03	6.63 nails Standard Deviation 3.32	5.09 nails Standard Deviation 3.84
Number of Affected Nails Week 52 (n= 110, 148, 21, 32)	3.44 nails Standard Deviation 3.60	2.64 nails Standard Deviation 3.57	3.10 nails Standard Deviation 3.70	3.25 nails Standard Deviation 3.88

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. Here 'N' (number of participants analyzed) signifies those participants who were evaluable 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

Measure	CP-690,550 5 mg n=238 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=242 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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	2.58 percent change Standard Error 6.46	-19.37 percent change Standard Error 6.40	16.91 percent change Standard Error 17.18	36.22 percent change Standard Error 14.67
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	-14.13 percent change Standard Error 9.39	-42.26 percent change Standard Error 9.16	78.80 percent change Standard Error 24.22	50.19 percent change Standard Error 20.82
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	-32.74 percent change Standard Error 9.20	-52.62 percent change Standard Error 8.93	43.82 percent change Standard Error 23.46	38.66 percent change Standard Error 20.24
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 28	-43.52 percent change Standard Error 7.22	-65.20 percent change Standard Error 7.06	12.39 percent change Standard Error 18.71	-18.71 percent change Standard Error 15.95
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 40	-64.55 percent change Standard Error 4.05	-75.41 percent change Standard Error 3.57	-57.01 percent change Standard Error 9.38	-54.83 percent change Standard Error 8.02
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 Percent Change at Week 52	-58.27 percent change Standard Error 5.98	-73.56 percent change Standard Error 5.54	-45.67 percent change Standard Error 14.67	-72.42 percent change Standard Error 12.31

SECONDARY outcome

Timeframe: 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. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.

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. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.

Outcome measures

Measure	CP-690,550 5 mg n=247 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=250 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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	9.72 percentage of participants Interval 6.02 to 13.41	14.40 percentage of participants Interval 10.05 to 18.75	8.82 percentage of participants Interval 0.0 to 18.36	4.35 percentage of participants Interval 0.0 to 10.24
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 16	14.98 percentage of participants Interval 10.53 to 19.43	29.20 percentage of participants Interval 23.56 to 34.84	5.88 percentage of participants Interval 0.0 to 13.79	6.52 percentage of participants Interval 0.0 to 13.66
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 20	21.05 percentage of participants Interval 15.97 to 26.14	39.20 percentage of participants Interval 33.15 to 45.25	8.82 percentage of participants Interval 0.0 to 18.36	23.91 percentage of participants Interval 11.59 to 36.24
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 28	31.17 percentage of participants Interval 25.4 to 36.95	49.20 percentage of participants Interval 43.0 to 55.4	17.65 percentage of participants Interval 4.83 to 30.46	28.26 percentage of participants Interval 15.25 to 41.27
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 40	28.34 percentage of participants Interval 22.72 to 33.96	48.80 percentage of participants Interval 42.6 to 55.0	41.18 percentage of participants Interval 24.63 to 57.72	36.96 percentage of participants Interval 23.01 to 50.91
Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response Week 52	25.51 percentage of participants Interval 20.07 to 30.94	41.20 percentage of participants Interval 35.1 to 47.3	35.29 percentage of participants Interval 19.23 to 51.36	43.48 percentage of participants Interval 29.15 to 57.8

SECONDARY outcome

Timeframe: 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. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.

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. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.

Outcome measures

Measure	CP-690,550 5 mg n=247 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=250 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=34 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, CP-690,550 10 mg n=46 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	8.10 percentage of participants Interval 4.7 to 11.5	12.40 percentage of participants Interval 8.31 to 16.49	5.88 percentage of participants Interval 0.0 to 13.79	4.35 percentage of participants Interval 0.0 to 10.24
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 16	10.12 percentage of participants Interval 6.36 to 13.88	20.00 percentage of participants Interval 15.04 to 24.96	5.88 percentage of participants Interval 0.0 to 13.79	4.35 percentage of participants Interval 0.0 to 10.24
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 20	13.77 percentage of participants Interval 9.47 to 18.06	27.20 percentage of participants Interval 21.68 to 32.72	8.82 percentage of participants Interval 0.0 to 18.36	13.04 percentage of participants Interval 3.31 to 22.78
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 28	19.43 percentage of participants Interval 14.5 to 24.37	32.00 percentage of participants Interval 26.22 to 37.78	5.88 percentage of participants Interval 0.0 to 13.79	17.39 percentage of participants Interval 6.44 to 28.34
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 40	18.22 percentage of participants Interval 13.4 to 23.03	30.40 percentage of participants Interval 24.7 to 36.1	29.41 percentage of participants Interval 14.1 to 44.73	26.09 percentage of participants Interval 13.4 to 38.78
Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response Week 52	15.79 percentage of participants Interval 11.24 to 20.34	28.80 percentage of participants Interval 23.19 to 34.41	29.41 percentage of participants Interval 14.1 to 44.73	28.26 percentage of participants Interval 15.25 to 41.27

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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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=343,341,62,58)	5.49 units on a scale Standard Deviation 2.81	5.59 units on a scale Standard Deviation 2.72	5.64 units on a scale Standard Deviation 2.65	5.94 units on a scale Standard Deviation 2.94
Itch Severity Item (ISI) Score Week 2 (n=357,358,66,64)	3.74 units on a scale Standard Deviation 2.51	3.32 units on a scale Standard Deviation 2.56	5.45 units on a scale Standard Deviation 2.87	5.61 units on a scale Standard Deviation 3.04
Itch Severity Item (ISI) Score Week 4 (n=351,350,64,66)	2.89 units on a scale Standard Deviation 2.44	2.41 units on a scale Standard Deviation 2.28	5.36 units on a scale Standard Deviation 2.86	5.56 units on a scale Standard Deviation 3.05
Itch Severity Item (ISI) Score Week 8 (n=347,348,65,66)	2.56 units on a scale Standard Deviation 2.60	1.87 units on a scale Standard Deviation 2.20	5.51 units on a scale Standard Deviation 2.94	5.50 units on a scale Standard Deviation 3.35
Itch Severity Item (ISI) Score Week 12 (n=343,344,65,66)	2.38 units on a scale Standard Deviation 2.66	1.62 units on a scale Standard Deviation 2.18	4.83 units on a scale Standard Deviation 3.11	5.42 units on a scale Standard Deviation 3.30
Itch Severity Item (ISI) Score Week 16 (n=322,335,66,66)	2.44 units on a scale Standard Deviation 2.70	1.48 units on a scale Standard Deviation 2.14	4.82 units on a scale Standard Deviation 3.11	5.83 units on a scale Standard Deviation 3.27
Itch Severity Item (ISI) Score Week 20 (n=312,319,66,65)	1.94 units on a scale Standard Deviation 2.20	1.43 units on a scale Standard Deviation 2.23	2.48 units on a scale Standard Deviation 2.27	2.48 units on a scale Standard Deviation 2.63
Itch Severity Item (ISI) Score Week 28 (n=293,306,61,61)	1.96 units on a scale Standard Deviation 2.41	1.41 units on a scale Standard Deviation 2.11	2.02 units on a scale Standard Deviation 2.31	1.62 units on a scale Standard Deviation 2.09
Itch Severity Item (ISI) Score Week 40 (n=202,242,53,47)	1.47 units on a scale Standard Deviation 2.15	1.01 units on a scale Standard Deviation 1.77	1.43 units on a scale Standard Deviation 2.03	0.83 units on a scale Standard Deviation 1.54
Itch Severity Item (ISI) Score Week 52 (n=179,218,47,46)	1.35 units on a scale Standard Deviation 2.00	0.83 units on a scale Standard Deviation 1.53	1.60 units on a scale Standard Deviation 2.09	0.93 units on a scale Standard Deviation 1.44

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. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

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.

Outcome measures

Measure	CP-690,550 5 mg n=340 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=339 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=62 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, CP-690,550 10 mg n=58 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	-1.76 units on a scale Standard Error 0.10	-2.25 units on a scale Standard Error 0.11	-0.13 units on a scale Standard Error 0.25	-0.06 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 4	-2.62 units on a scale Standard Error 0.11	-3.16 units on a scale Standard Error 0.11	-0.27 units on a scale Standard Error 0.26	-0.11 units on a scale Standard Error 0.27
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	-2.95 units on a scale Standard Error 0.13	-3.72 units on a scale Standard Error 0.13	-0.01 units on a scale Standard Error 0.29	-0.18 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 12	-3.02 units on a scale Standard Error 0.13	-3.91 units on a scale Standard Error 0.13	-0.79 units on a scale Standard Error 0.30	-0.25 units on a scale Standard Error 0.31
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	-2.85 units on a scale Standard Error 0.14	-3.97 units on a scale Standard Error 0.14	-0.77 units on a scale Standard Error 0.31	0.17 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 20	-3.31 units on a scale Standard Error 0.13	-3.98 units on a scale Standard Error 0.13	-3.11 units on a scale Standard Error 0.29	-3.16 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 28	-3.25 units on a scale Standard Error 0.14	-3.94 units on a scale Standard Error 0.13	-3.59 units on a scale Standard Error 0.30	-4.16 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 40	-3.07 units on a scale Standard Error 0.15	-3.88 units on a scale Standard Error 0.14	-3.84 units on a scale Standard Error 0.32	-4.40 units on a scale Standard Error 0.34
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	-3.05 units on a scale Standard Error 0.15	-3.89 units on a scale Standard Error 0.14	-3.50 units on a scale Standard Error 0.32	-4.17 units on a scale Standard Error 0.33

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. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.

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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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=363,359,66,66)	12.46 units on a scale Standard Deviation 6.89	12.87 units on a scale Standard Deviation 6.91	13.83 units on a scale Standard Deviation 6.97	14.68 units on a scale Standard Deviation 6.80
Dermatology Life Quality Index (DLQI) Score Week 2 (n=356,357,66,64)	8.65 units on a scale Standard Deviation 6.11	8.32 units on a scale Standard Deviation 6.45	11.44 units on a scale Standard Deviation 7.02	12.67 units on a scale Standard Deviation 7.06
Dermatology Life Quality Index (DLQI) Score Week 4 (n=351,349,65,66)	6.98 units on a scale Standard Deviation 5.97	6.50 units on a scale Standard Deviation 5.94	11.45 units on a scale Standard Deviation 6.87	13.05 units on a scale Standard Deviation 7.14
Dermatology Life Quality Index (DLQI) Score Week 8 (n=345,347,65,66)	5.88 units on a scale Standard Deviation 6.00	4.95 units on a scale Standard Deviation 5.58	10.89 units on a scale Standard Deviation 6.23	13.05 units on a scale Standard Deviation 7.49
Dermatology Life Quality Index (DLQI) Score Week 12 (n=340,344,65,66)	5.36 units on a scale Standard Deviation 6.06	4.17 units on a scale Standard Deviation 5.10	10.29 units on a scale Standard Deviation 6.82	13.06 units on a scale Standard Deviation 7.58
Dermatology Life Quality Index (DLQI) Score Week 16 (n=319,331,66,66)	5.45 units on a scale Standard Deviation 6.07	3.85 units on a scale Standard Deviation 5.17	10.05 units on a scale Standard Deviation 6.23	12.83 units on a scale Standard Deviation 7.80
Dermatology Life Quality Index (DLQI) Score Week 20 (n=310,319,66,65)	4.28 units on a scale Standard Deviation 5.18	3.26 units on a scale Standard Deviation 4.67	5.89 units on a scale Standard Deviation 4.88	7.17 units on a scale Standard Deviation 6.69
Dermatology Life Quality Index (DLQI) Score Week 28 (n=289,303,61,61)	3.94 units on a scale Standard Deviation 5.05	3.24 units on a scale Standard Deviation 4.83	4.34 units on a scale Standard Deviation 4.88	3.46 units on a scale Standard Deviation 4.27
Dermatology Life Quality Index (DLQI) Score Week 40 (n=200,239,53,46)	2.53 units on a scale Standard Deviation 4.11	2.11 units on a scale Standard Deviation 3.79	3.25 units on a scale Standard Deviation 4.43	1.63 units on a scale Standard Deviation 2.17
Dermatology Life Quality Index (DLQI) Score Week 52 (n=177,216,47,46)	2.86 units on a scale Standard Deviation 4.35	1.91 units on a scale Standard Deviation 3.72	3.40 units on a scale Standard Deviation 4.43	1.78 units on a scale Standard Deviation 2.44

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. 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

Measure	CP-690,550 5 mg n=358 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=357 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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	-4.02 units on a scale Standard Error 0.23	-4.56 units on a scale Standard Error 0.23	-1.94 units on a scale Standard Error 0.54	-1.07 units on a scale Standard Error 0.54
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	-5.65 units on a scale Standard Error 0.25	-6.41 units on a scale Standard Error 0.25	-1.90 units on a scale Standard Error 0.57	-0.77 units on a scale Standard Error 0.57
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	-6.68 units on a scale Standard Error 0.27	-7.95 units on a scale Standard Error 0.27	-2.45 units on a scale Standard Error 0.61	-0.77 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 12	-7.09 units on a scale Standard Error 0.27	-8.70 units on a scale Standard Error 0.27	-3.08 units on a scale Standard Error 0.63	-0.75 units on a scale Standard Error 0.63
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	-6.97 units on a scale Standard Error 0.29	-8.90 units on a scale Standard Error 0.28	-3.33 units on a scale Standard Error 0.65	-0.98 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 20	-8.01 units on a scale Standard Error 0.27	-9.42 units on a scale Standard Error 0.27	-7.48 units on a scale Standard Error 0.61	-6.48 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 28	-8.25 units on a scale Standard Error 0.28	-9.36 units on a scale Standard Error 0.28	-9.02 units on a scale Standard Error 0.62	-9.72 units on a scale Standard Error 0.62
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	-8.50 units on a scale Standard Error 0.30	-9.51 units on a scale Standard Error 0.29	-9.26 units on a scale Standard Error 0.63	-10.89 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	-8.26 units on a scale Standard Error 0.31	-9.56 units on a scale Standard Error 0.30	-9.23 units on a scale Standard Error 0.65	-10.90 units on a scale Standard Error 0.66

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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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) Week 16: Physical Health Score (n=318,329,65,65)	49.83 units on a scale Standard Deviation 8.34	50.99 units on a scale Standard Deviation 8.63	48.04 units on a scale Standard Deviation 8.75	45.60 units on a scale Standard Deviation 8.87
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 16: Mental Health Score (n=318,329,65,65)	47.23 units on a scale Standard Deviation 10.93	49.06 units on a scale Standard Deviation 9.50	44.47 units on a scale Standard Deviation 10.77	43.07 units on a scale Standard Deviation 12.34
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 28: Physical Health Score (n=286,303,60,61)	51.01 units on a scale Standard Deviation 7.67	51.92 units on a scale Standard Deviation 7.86	51.11 units on a scale Standard Deviation 8.08	49.63 units on a scale Standard Deviation 8.52
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 28: Mental Health Score (n=286,303,60,61)	48.59 units on a scale Standard Deviation 10.47	49.64 units on a scale Standard Deviation 9.35	48.63 units on a scale Standard Deviation 9.57	49.69 units on a scale Standard Deviation 9.71
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 52: Physical Health Score (n=177,216,46,46)	51.98 units on a scale Standard Deviation 7.10	52.42 units on a scale Standard Deviation 7.93	50.90 units on a scale Standard Deviation 8.75	52.12 units on a scale Standard Deviation 7.64
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Week 52: Mental Health Score (n=177,216,46,46)	49.05 units on a scale Standard Deviation 10.33	50.73 units on a scale Standard Deviation 8.38	50.77 units on a scale Standard Deviation 9.43	49.58 units on a scale Standard Deviation 9.67
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Baseline: Physical Health Score (n=358,355,66,66)	47.36 units on a scale Standard Deviation 9.10	47.02 units on a scale Standard Deviation 9.05	47.12 units on a scale Standard Deviation 8.95	44.86 units on a scale Standard Deviation 9.12
36-Item Short-Form Health Survey Version 2, Acute (SF-36) Baseline: Mental Health Score (n=358,355,66,66)	42.98 units on a scale Standard Deviation 12.53	43.35 units on a scale Standard Deviation 11.57	42.53 units on a scale Standard Deviation 11.77	42.97 units on a scale Standard Deviation 11.44

SECONDARY outcome

Timeframe: Baseline, Week 4, 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. 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 option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 Subscale (n=362,358,66,66)	6.58 units on a scale Standard Deviation 4.21	6.21 units on a scale Standard Deviation 4.08	6.94 units on a scale Standard Deviation 4.21	7.06 units on a scale Standard Deviation 4.02
Hospital Anxiety and Depression Scale (HADS) Score Baseline: Depression Subscale (n=362,358,66,66)	5.20 units on a scale Standard Deviation 4.27	5.09 units on a scale Standard Deviation 4.09	5.61 units on a scale Standard Deviation 3.98	5.68 units on a scale Standard Deviation 3.93
Hospital Anxiety and Depression Scale (HADS) Score Week 4: Anxiety Subscale (n=350,349,65,66)	5.66 units on a scale Standard Deviation 3.96	5.30 units on a scale Standard Deviation 3.90	6.82 units on a scale Standard Deviation 4.11	6.70 units on a scale Standard Deviation 4.12
Hospital Anxiety and Depression Scale (HADS) Score Week 4: Depression Subscale (n=350,349,65,66)	4.34 units on a scale Standard Deviation 3.59	4.23 units on a scale Standard Deviation 3.75	5.28 units on a scale Standard Deviation 4.06	5.26 units on a scale Standard Deviation 4.12
Hospital Anxiety and Depression Scale (HADS) Score Week 16: Anxiety Subscale (n=317,333,65,66)	5.50 units on a scale Standard Deviation 4.18	4.74 units on a scale Standard Deviation 3.76	6.20 units on a scale Standard Deviation 4.39	6.85 units on a scale Standard Deviation 4.50
Hospital Anxiety and Depression Scale (HADS) Score Week 16: Depression Subscale (n=317,333,65,66)	3.97 units on a scale Standard Deviation 3.87	3.51 units on a scale Standard Deviation 3.71	4.92 units on a scale Standard Deviation 3.65	5.50 units on a scale Standard Deviation 4.07
Hospital Anxiety and Depression Scale (HADS) Score Week 28: Anxiety Subscale (n=286,304,60,61)	4.98 units on a scale Standard Deviation 4.04	4.47 units on a scale Standard Deviation 4.00	4.60 units on a scale Standard Deviation 3.89	4.82 units on a scale Standard Deviation 3.88
Hospital Anxiety and Depression Scale (HADS) Score Week 28: Depression Subscale (n=286,304,60,61)	3.63 units on a scale Standard Deviation 3.64	3.21 units on a scale Standard Deviation 3.65	3.65 units on a scale Standard Deviation 3.66	3.59 units on a scale Standard Deviation 3.25
Hospital Anxiety and Depression Scale (HADS) Score Week 52: Anxiety Subscale (n=177,215,46,46)	3.97 units on a scale Standard Deviation 3.65	3.84 units on a scale Standard Deviation 3.88	4.33 units on a scale Standard Deviation 4.21	4.00 units on a scale Standard Deviation 3.81
Hospital Anxiety and Depression Scale (HADS) Score Week 52:Depression Subscale (n= 177, 215, 46, 46)	3.05 units on a scale Standard Deviation 3.48	2.80 units on a scale Standard Deviation 3.49	3.11 units on a scale Standard Deviation 3.16	3.09 units on a scale Standard Deviation 3.03

SECONDARY outcome

Timeframe: Baseline, Week 4, 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. 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 items); 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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= 309, 305, 55, 56)	7.40 units on a scale Standard Deviation 6.38	7.90 units on a scale Standard Deviation 6.51	7.16 units on a scale Standard Deviation 5.84	8.40 units on a scale Standard Deviation 6.01
Work Limitation Questionnaire (WLQ) Index Score Week 4 (n= 291, 298, 53, 55)	6.92 units on a scale Standard Deviation 6.68	6.64 units on a scale Standard Deviation 6.42	6.67 units on a scale Standard Deviation 6.41	9.66 units on a scale Standard Deviation 6.55
Work Limitation Questionnaire (WLQ) Index Score Week 16 (n= 273, 279, 51, 55)	6.68 units on a scale Standard Deviation 6.37	5.72 units on a scale Standard Deviation 5.93	6.53 units on a scale Standard Deviation 5.97	7.13 units on a scale Standard Deviation 5.69
Work Limitation Questionnaire (WLQ) Index Score Week 28 (n= 241, 254, 51, 53)	6.12 units on a scale Standard Deviation 6.37	5.77 units on a scale Standard Deviation 6.29	6.03 units on a scale Standard Deviation 6.29	6.24 units on a scale Standard Deviation 6.36
Work Limitation Questionnaire (WLQ) Index Score Week 52 (n= 148, 183, 41, 41)	6.02 units on a scale Standard Deviation 6.26	5.95 units on a scale Standard Deviation 6.65	6.73 units on a scale Standard Deviation 6.54	5.29 units on a scale Standard Deviation 6.49

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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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: Severe (n = 360, 359, 66, 66)	62.8 percentage of participants	60.7 percentage of participants	65.2 percentage of participants	63.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline: Almost Clear (n = 360, 359, 66, 66)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline: Clear (n = 360, 359, 66, 66)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline: Mild (n = 360, 359, 66, 66)	1.9 percentage of participants	3.6 percentage of participants	3.0 percentage of participants	1.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Baseline: Moderate (n = 360, 359, 66, 66)	35.3 percentage of participants	35.7 percentage of participants	31.8 percentage of participants	34.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2: Clear (n = 357, 358, 66, 64)	0.0 percentage of participants	0.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2: Almost Clear (n = 357, 358, 66, 64)	1.1 percentage of participants	3.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2: Mild (n = 357, 358, 66, 64)	14.8 percentage of participants	17.6 percentage of participants	7.6 percentage of participants	6.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2: Moderate (n = 357, 358, 66, 64)	51.0 percentage of participants	48.0 percentage of participants	37.9 percentage of participants	40.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 2: Severe (n = 357, 358, 66, 64)	33.1 percentage of participants	30.2 percentage of participants	54.5 percentage of participants	53.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4: Clear (n = 350, 348, 65, 65)	0.0 percentage of participants	0.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4: Almost Clear (n = 350, 348, 65, 65)	10.0 percentage of participants	12.1 percentage of participants	1.5 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4: Mild (n = 350, 348, 65, 65)	24.6 percentage of participants	29.9 percentage of participants	7.7 percentage of participants	4.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4: Moderate (n = 350, 348, 65, 65)	42.9 percentage of participants	40.5 percentage of participants	46.2 percentage of participants	36.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 4: Severe (n = 350, 348, 65, 65)	22.6 percentage of participants	16.7 percentage of participants	44.6 percentage of participants	58.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8: Clear (n = 345, 346, 65, 66)	1.7 percentage of participants	3.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8: Almost Clear (n = 345, 346, 65, 66)	19.7 percentage of participants	27.7 percentage of participants	1.5 percentage of participants	1.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8: Mild (n = 345, 346, 65, 66)	29.3 percentage of participants	28.9 percentage of participants	12.3 percentage of participants	6.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8: Moderate (n = 345, 346, 65, 66)	30.1 percentage of participants	27.2 percentage of participants	43.1 percentage of participants	39.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 8: Severe (n = 345, 346, 65, 66)	19.1 percentage of participants	12.4 percentage of participants	43.1 percentage of participants	53.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12: Clear (n = 341, 344, 65, 65)	3.8 percentage of participants	8.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12: Almost Clear (n = 341, 344, 65, 65)	24.9 percentage of participants	35.2 percentage of participants	3.1 percentage of participants	3.1 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12: Mild (n = 341, 344, 65, 65)	29.6 percentage of participants	27.9 percentage of participants	23.1 percentage of participants	7.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12: Moderate (n = 341, 344, 65, 65)	24.3 percentage of participants	19.5 percentage of participants	32.3 percentage of participants	33.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 12: Severe (n = 341, 344, 65, 65)	17.3 percentage of participants	8.7 percentage of participants	41.5 percentage of participants	55.4 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16: Clear (n = 320, 331, 66, 66)	3.4 percentage of participants	10.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16: Almost Clear (n = 320, 331, 66, 66)	28.4 percentage of participants	37.8 percentage of participants	6.1 percentage of participants	3.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16: Mild (n = 320, 331, 66, 66)	30.6 percentage of participants	24.8 percentage of participants	15.2 percentage of participants	10.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16: Moderate (n = 320, 331, 66, 66)	22.5 percentage of participants	19.0 percentage of participants	42.4 percentage of participants	25.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 16: Severe (n = 320, 331, 66, 66)	15.0 percentage of participants	7.6 percentage of participants	36.4 percentage of participants	60.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20: Clear (n = 311, 319, 65, 64)	6.1 percentage of participants	16.3 percentage of participants	0.0 percentage of participants	1.6 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20: Almost Clear (n = 311, 319, 65, 64)	34.1 percentage of participants	35.7 percentage of participants	23.1 percentage of participants	20.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20: Mild (n = 311, 319, 65, 64)	28.6 percentage of participants	27.3 percentage of participants	26.2 percentage of participants	20.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20: Moderate (n = 311, 319, 65, 64)	23.5 percentage of participants	13.5 percentage of participants	46.2 percentage of participants	35.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 20: Severe (n = 311, 319, 65, 64)	7.7 percentage of participants	7.2 percentage of participants	4.6 percentage of participants	21.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28: Clear (n = 290, 303, 61, 61)	11.7 percentage of participants	20.8 percentage of participants	6.6 percentage of participants	14.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28: Almost Clear (n = 290, 303, 61, 61)	36.9 percentage of participants	40.6 percentage of participants	32.8 percentage of participants	39.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28: Mild (n = 290, 303, 61, 61)	19.3 percentage of participants	17.5 percentage of participants	39.3 percentage of participants	29.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28: Moderate (n = 290, 303, 61, 61)	25.2 percentage of participants	15.8 percentage of participants	19.7 percentage of participants	11.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 28: Severe (n = 290, 303, 61, 61)	6.9 percentage of participants	5.3 percentage of participants	1.6 percentage of participants	4.9 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Clear (n = 200, 239, 53, 46)	18.5 percentage of participants	30.5 percentage of participants	11.3 percentage of participants	28.3 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Almost Clear (n = 200, 239, 53, 46)	44.0 percentage of participants	41.4 percentage of participants	50.9 percentage of participants	56.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Mild (n = 200, 239, 53, 46)	18.5 percentage of participants	15.5 percentage of participants	20.8 percentage of participants	15.2 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Moderate (n = 200, 239, 53, 46)	16.0 percentage of participants	11.3 percentage of participants	15.1 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 40: Severe (n = 200, 239, 53, 46)	3.0 percentage of participants	1.3 percentage of participants	1.9 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52: Clear (n = 177, 216, 47, 46)	14.1 percentage of participants	32.9 percentage of participants	19.1 percentage of participants	34.8 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52: Almost Clear (n = 177, 216, 47, 46)	45.8 percentage of participants	39.8 percentage of participants	31.9 percentage of participants	45.7 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52: Mild (n = 177, 216, 47, 46)	17.5 percentage of participants	15.3 percentage of participants	23.4 percentage of participants	13.0 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52: Moderate (n = 177, 216, 47, 46)	16.4 percentage of participants	9.3 percentage of participants	21.3 percentage of participants	6.5 percentage of participants
Percentage of Participants With Patient Global Assessment (PtGA) Scale Response Week 52: Severe (n = 177, 216, 47, 46)	6.2 percentage of participants	2.8 percentage of participants	4.3 percentage of participants	0.0 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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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=317,332,65,66)	6.0 percentage of participants	6.3 percentage of participants	12.3 percentage of participants	13.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Slightly Dissatisfied (n=317,332,65,66)	3.2 percentage of participants	1.5 percentage of participants	9.2 percentage of participants	7.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Slightly Satisfied (n=317,332,65,66)	7.9 percentage of participants	6.9 percentage of participants	9.2 percentage of participants	12.1 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Somewhat Dissatisfied (n=317,332,65,66)	6.0 percentage of participants	3.0 percentage of participants	9.2 percentage of participants	18.2 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Somewhat Satisfied (n=317,332,65,66)	22.1 percentage of participants	22.9 percentage of participants	16.9 percentage of participants	7.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Very Dissatisfied (n=317,332,65,66)	5.4 percentage of participants	4.2 percentage of participants	29.2 percentage of participants	33.3 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 16:Very Satisfied (n=317,332,65,66)	49.5 percentage of participants	55.1 percentage of participants	13.8 percentage of participants	7.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week28:Not Satisfied/Dissatisfied(n=285,303,60,61)	2.1 percentage of participants	4.0 percentage of participants	1.7 percentage of participants	3.3 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Slightly Dissatisfied (n=285,303,60,61)	4.6 percentage of participants	3.3 percentage of participants	1.7 percentage of participants	1.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Slightly Satisfied (n=285,303,60,61)	10.5 percentage of participants	6.9 percentage of participants	11.7 percentage of participants	3.3 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Somewhat Dissatisfied (n=285,303,60,61)	3.9 percentage of participants	0.7 percentage of participants	0.0 percentage of participants	1.6 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Somewhat Satisfied (n=285,303,60,61)	27.0 percentage of participants	26.1 percentage of participants	40.0 percentage of participants	31.1 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Very Dissatisfied (n=285,303,60,61)	2.5 percentage of participants	3.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 28:Very Satisfied (n=285,303,60,61)	49.5 percentage of participants	55.4 percentage of participants	45.0 percentage of participants	59.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week52:Not Satisfied/Dissatisfied(n=176,217,46,46)	2.8 percentage of participants	0.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Slightly Dissatisfied (n=176,217,46,46)	1.1 percentage of participants	0.9 percentage of participants	2.2 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Slightly Satisfied (n=176,217,46,46)	5.1 percentage of participants	5.5 percentage of participants	13.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Somewhat Dissatisfied (n=176,217,46,46)	2.3 percentage of participants	0.9 percentage of participants	2.2 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Somewhat Satisfied (n=176,217,46,46)	33.5 percentage of participants	25.3 percentage of participants	34.8 percentage of participants	28.3 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Very Dissatisfied (n=176,217,46,46)	0.0 percentage of participants	0.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response Week 52:Very Satisfied (n=176,217,46,46)	55.1 percentage of participants	65.4 percentage of participants	47.8 percentage of participants	71.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 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. 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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 Week 4 (n= 351, 349, 64, 66)	2.24 units on a scale Standard Deviation 2.57	2.13 units on a scale Standard Deviation 2.56	3.13 units on a scale Standard Deviation 2.68	3.18 units on a scale Standard Deviation 3.19
Joint Pain Assessment (JPA) Score Week 16 (n= 319, 333, 65, 66)	2.41 units on a scale Standard Deviation 2.76	1.89 units on a scale Standard Deviation 2.59	3.20 units on a scale Standard Deviation 3.07	3.45 units on a scale Standard Deviation 3.22
Joint Pain Assessment (JPA) Score Baseline (n= 363, 359, 66, 65)	3.42 units on a scale Standard Deviation 3.21	2.96 units on a scale Standard Deviation 2.99	3.00 units on a scale Standard Deviation 2.94	3.69 units on a scale Standard Deviation 3.15
Joint Pain Assessment (JPA) Score Week 28 (n= 287, 304, 60, 60)	2.08 units on a scale Standard Deviation 2.53	1.71 units on a scale Standard Deviation 2.46	1.93 units on a scale Standard Deviation 2.18	1.93 units on a scale Standard Deviation 2.36
Joint Pain Assessment (JPA) Score Week 52 (n= 176, 215, 46, 46)	1.60 units on a scale Standard Deviation 2.25	1.38 units on a scale Standard Deviation 2.25	1.46 units on a scale Standard Deviation 2.24	1.50 units on a scale Standard Deviation 2.41

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

Outcome measures

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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= 363, 359, 66, 65)	0.77 units on a scale Standard Deviation 0.19	0.77 units on a scale Standard Deviation 0.19	0.78 units on a scale Standard Deviation 0.17	0.74 units on a scale Standard Deviation 0.19
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 16 (n= 319, 333, 65, 65)	0.86 units on a scale Standard Deviation 0.16	0.88 units on a scale Standard Deviation 0.15	0.81 units on a scale Standard Deviation 0.18	0.76 units on a scale Standard Deviation 0.19
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 28 (n= 288, 303, 60, 61)	0.86 units on a scale Standard Deviation 0.15	0.89 units on a scale Standard Deviation 0.14	0.89 units on a scale Standard Deviation 0.14	0.88 units on a scale Standard Deviation 0.13
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 40 (n= 201, 239, 53, 46)	0.91 units on a scale Standard Deviation 0.13	0.91 units on a scale Standard Deviation 0.15	0.92 units on a scale Standard Deviation 0.14	0.90 units on a scale Standard Deviation 0.16
Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score Week 52 (n= 176, 217, 47, 46)	0.89 units on a scale Standard Deviation 0.12	0.90 units on a scale Standard Deviation 0.14	0.89 units on a scale Standard Deviation 0.14	0.90 units on a scale Standard Deviation 0.13

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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=66 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, CP-690,550 10 mg n=66 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= 361, 359, 65, 66)	67.28 mm Standard Deviation 22.53	66.97 mm Standard Deviation 22.63	68.65 mm Standard Deviation 21.20	65.24 mm Standard Deviation 19.61
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 16 (n= 316, 330, 64, 66)	76.00 mm Standard Deviation 18.96	77.95 mm Standard Deviation 17.36	69.00 mm Standard Deviation 17.95	59.85 mm Standard Deviation 22.92
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 28 (n= 287, 303, 60, 61)	77.99 mm Standard Deviation 17.89	78.89 mm Standard Deviation 17.38	76.37 mm Standard Deviation 18.10	79.13 mm Standard Deviation 12.80
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 40 (n= 201, 240, 53, 46)	81.47 mm Standard Deviation 17.74	83.84 mm Standard Deviation 15.09	82.96 mm Standard Deviation 12.25	83.80 mm Standard Deviation 12.62
Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Week 52 (n= 175, 216, 47, 45)	80.23 mm Standard Deviation 17.42	84.59 mm Standard Deviation 13.80	81.23 mm Standard Deviation 14.54	82.38 mm Standard Deviation 13.73

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). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and '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, 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.

Outcome measures

Measure	CP-690,550 5 mg n=56 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=57 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=23 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, 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: Surgeon (n= 28, 39, 15)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Nurse (n= 28, 39, 15)	9 events	5 events	3 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Other (n= 28, 39, 15)	1 events	2 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: General Practitioner (n= 56, 57, 23)	33 events	32 events	12 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Dermatologist (n= 56, 57, 23)	14 events	22 events	8 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Rheumatologist (n= 56, 57, 23)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Cardiologist (n= 56, 57, 23)	1 events	0 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Gastroenterologist (n= 56, 57, 23)	0 events	0 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Psychiatrist (n= 56, 57, 23)	2 events	3 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Surgeon (n= 56, 57, 23)	4 events	3 events	1 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Nurse (n= 56, 57, 23)	2 events	4 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Week 16: Other (n= 56, 57, 23)	23 events	18 events	7 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: General Practitioner (n= 28, 39, 15)	3 events	5 events	2 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Dermatologist (n= 28, 39, 15)	24 events	34 events	14 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Rheumatologist (n= 28, 39, 15)	0 events	1 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Cardiologist (n= 28, 39, 15)	0 events	1 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Gastroenterologist (n= 28, 39, 15)	0 events	0 events	0 events	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional Baseline: Psychiatrist (n= 28, 39, 15)	0 events	0 events	0 events	—

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). 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 employed at the time of assessment answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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=237,232,114)	55 participants	47 participants	27 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline: Emp, Absent/Sick Leave:N (n=237,232,114)	182 participants	185 participants	87 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline: UEmp, due to Psoriasis:Y (n=97,103,49)	15 participants	24 participants	4 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Baseline: UEmp, due to Psoriasis:N (n=97,103,49)	82 participants	79 participants	45 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16: Emp, Absent/Sick Leave:Y (n=224,221,88)	47 participants	37 participants	24 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16: Emp, Absent/Sick Leave:N (n=224,221,88)	177 participants	184 participants	64 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16: UEmp, due to Psoriasis:Y (n=77,87,42)	10 participants	13 participants	6 participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work Week 16:UEmp, due to Psoriasis: N (n=77,87,42)	67 participants	74 participants	36 participants	—

SECONDARY outcome

Timeframe: 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). Here 'n' signifies those 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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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=30,37,5)	100.00 percentage of participants	94.59 percentage of participants	100.00 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Employment (n=301,310,130)	74.42 percentage of participants	71.94 percentage of participants	66.92 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Work Impacted Events (n=79,88,42)	12.66 percentage of participants	14.77 percentage of participants	14.29 percentage of participants	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status Absence/Sick Leave Due to Psoriasis (n=224,221,90)	20.98 percentage of participants	16.74 percentage of participants	27.78 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). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable 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.

Outcome measures

Measure	CP-690,550 5 mg n=54 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=48 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, 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 Baseline: Hours Scheduled to Work (n=54,48,25)	8.61 hours Standard Deviation 1.31	8.15 hours Standard Deviation 1.75	7.92 hours Standard Deviation 0.91	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Baseline: Hours Absent From Work (n=54,47,27)	5.15 hours Standard Deviation 3.09	6.00 hours Standard Deviation 3.03	5.81 hours Standard Deviation 2.48	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Week 16: Hours Scheduled to Work (n=47,39,25)	8.49 hours Standard Deviation 1.80	8.31 hours Standard Deviation 1.08	8.40 hours Standard Deviation 1.63	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours Week 16: Hours Absent From Work (n=46,38,24)	5.41 hours Standard Deviation 3.15	5.24 hours Standard Deviation 2.39	5.88 hours Standard Deviation 2.40	—

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). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and '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 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.

Outcome measures

Measure	CP-690,550 5 mg n=53 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=25 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, 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=53,47,25)	60.32 percentage of scheduled hours Standard Deviation 33.29	72.84 percentage of scheduled hours Standard Deviation 32.96	75.76 percentage of scheduled hours Standard Deviation 30.04	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours Week 16 (n=46,38,24)	64.15 percentage of scheduled hours Standard Deviation 35.08	65.21 percentage of scheduled hours Standard Deviation 31.55	71.81 percentage of scheduled hours Standard Deviation 30.99	—

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). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and '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

Measure	CP-690,550 5 mg n=363 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=177 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, 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=238,234,114)	2.23 units on a scale Standard Deviation 2.81	2.13 units on a scale Standard Deviation 2.64	2.89 units on a scale Standard Deviation 3.07	—
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work Week 16 (n=223,222,89)	1.13 units on a scale Standard Deviation 2.13	1.26 units on a scale Standard Deviation 2.60	1.94 units on a scale Standard Deviation 2.53	—

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. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and '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.

Outcome measures

Measure	CP-690,550 5 mg n=22 Participants CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=27 Participants CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo n=5 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, CP-690,550 10 mg n=5 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= 22, 27, 5, 5)	9.45 units on a scale Standard Deviation 7.40	9.41 units on a scale Standard Deviation 7.45	9.40 units on a scale Standard Deviation 3.78	8.80 units on a scale Standard Deviation 3.03
Family Dermatology Life Quality Index (FDLQI) Score Week 16 (n= 17, 17, 5, 5)	3.76 units on a scale Standard Deviation 4.25	3.53 units on a scale Standard Deviation 4.16	6.20 units on a scale Standard Deviation 5.26	6.40 units on a scale Standard Deviation 4.28
Family Dermatology Life Quality Index (FDLQI) Score Week 52 (n= 6, 9, 3, 2)	1.17 units on a scale Standard Deviation 2.40	2.00 units on a scale Standard Deviation 4.21	5.67 units on a scale Standard Deviation 3.51	0.50 units on a scale Standard Deviation 0.71

Adverse Events

CP-690,550 5 mg

Serious events: 24 serious events

Other events: 189 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 19 serious events

Other events: 222 other events

Deaths: 0 deaths

Placebo, CP-690,550 5 mg

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo, CP-690,550 10 mg

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	CP-690,550 5 mg n=363 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo, CP-690,550 5 mg n=66 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, CP-690,550 10 mg n=66 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=45 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.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Blood and lymphatic system disorders Neutropenia	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Atrial fibrillation	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Atrial flutter	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Myocardial infarction	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Myocardial ischaemia	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Myocarditis	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Haemorrhoids	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Tooth disorder	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Umbilical hernia	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Umbilical hernia, obstructive	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Chest pain	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Non-cardiac chest pain	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Pelvic mass	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Hepatobiliary disorders Cholecystitis acute	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Hepatobiliary disorders Hepatic failure	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Immune system disorders Anaphylactic reaction	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Appendicitis	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Bronchitis	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Burn infection	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Diverticulitis	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Herpes zoster	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Lung infection	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Meningitis aseptic	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pneumonia	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pyelonephritis	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Skin infection	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Staphylococcal skin infection	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Subcutaneous abscess	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Viral infection	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Contusion	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Excoriation	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Joint dislocation	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Tendon rupture	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Mycobacterium test positive	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Bursitis	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Cerebral infarction	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Syncope	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Alcohol abuse	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Depression	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Obsessive-compulsive disorder	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Renal and urinary disorders Nephrolithiasis	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.

Other adverse events

Measure	CP-690,550 5 mg n=363 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 52.	CP-690,550 10 mg n=360 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 52.	Placebo, CP-690,550 5 mg n=66 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, CP-690,550 10 mg n=66 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=45 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.
Metabolism and nutrition disorders Gout	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.4% 2/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hypercholesterolaemia	4.1% 15/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.7% 17/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hyperlipidaemia	2.8% 10/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	5.0% 18/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.7% 6/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Haemoglobin decreased	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Low density lipoprotein increased	2.8% 10/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.8% 10/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Blood and lymphatic system disorders Lymphadenopathy	1.4% 5/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Cardiac disorders Tachycardia	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Abdominal pain	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	6.1% 4/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Abdominal pain upper	2.2% 8/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Dental caries	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Diarrhoea	3.3% 12/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.6% 13/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Dyspepsia	1.9% 7/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.4% 5/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.4% 2/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Food poisoning	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Gastritis	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Nausea	3.3% 12/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.6% 13/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	7.6% 5/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Gastrointestinal disorders Toothache	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.5% 9/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Chest pain	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Fatigue	2.2% 8/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.7% 6/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.4% 2/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Hyperthermia	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Oedema peripheral	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
General disorders Pain	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Cellulitis	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Folliculitis	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 8/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Gastroenteritis	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.5% 9/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Gastroenteritis viral	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.7% 6/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Herpes zoster	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 8/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Influenza	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.1% 11/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Lower respiratory tract infection	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Nasopharyngitis	10.5% 38/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	15.3% 55/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	16.7% 11/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	13.6% 9/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	8.9% 4/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Oral herpes	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Pharyngitis	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Respiratory tract infection viral	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Rhinitis	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Sinusitis	1.9% 7/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.4% 5/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Upper respiratory tract infection	9.1% 33/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	9.7% 35/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	6.1% 4/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	6.1% 4/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Infections and infestations Urinary tract infection	3.3% 12/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.3% 12/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	7.6% 5/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Hand fracture	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Limb injury	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Injury, poisoning and procedural complications Muscle strain	1.1% 4/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Bacterial test positive	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Blood cholesterol increased	2.5% 9/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.6% 13/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Blood creatine phosphokinase increased	7.2% 26/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	10.6% 38/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	10.6% 7/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Blood triglycerides increased	1.7% 6/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.4% 5/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Investigations Gamma-glutamyltransferase increased	2.2% 8/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.5% 9/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	6.1% 4/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Metabolism and nutrition disorders Hypokalaemia	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 12/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.1% 11/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	7.6% 5/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Back pain	3.0% 11/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.7% 6/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Myalgia	2.2% 8/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.83% 3/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.28% 1/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.4% 5/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Dizziness	1.9% 7/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Nervous system disorders Headache	7.7% 28/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	7.8% 28/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	6.1% 4/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Insomnia	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Psychiatric disorders Nervousness	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 8/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.9% 7/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.7% 6/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.7% 6/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.83% 3/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	3.0% 2/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Acne	1.4% 5/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.5% 9/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.56% 2/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	28.9% 13/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Pruritus	0.55% 2/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.28% 1/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	4.5% 3/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	2.2% 1/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.
Skin and subcutaneous tissue disorders Psoriasis	2.5% 9/363 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.1% 4/360 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	1.5% 1/66 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.	0.00% 0/45 Same event may appear as both AE/SAE; distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. Adverse events for participants (n=45) who were not re-randomized at week 16, are reported separately.

Additional Information

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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