Trial Outcomes & Findings for A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02). (NCT NCT02222493)

Last Updated: 2018-05-30

Results Overview

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \[HAQ-DI\]); and C-Reactive Protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

650 participants

Primary outcome timeframe

Week 14

Results posted on

2018-05-30

Participant Flow

A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization.

Participant milestones

Participant milestones
Measure	PF-06438179 Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Infliximab-EU Remicade (INX) Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
Period 1: First Dose-Week 30 (Pre-dose) STARTED	324	326
Period 1: First Dose-Week 30 (Pre-dose) Received Treatment	323	326
Period 1: First Dose-Week 30 (Pre-dose) COMPLETED	280	286
Period 1: First Dose-Week 30 (Pre-dose) NOT COMPLETED	44	40
Period 2: Week30 Dosing-Week54(Pre-dose) STARTED	423	143
Period 2: Week30 Dosing-Week54(Pre-dose) COMPLETED	380	126
Period 2: Week30 Dosing-Week54(Pre-dose) NOT COMPLETED	43	17
Period 3: Week 54 Dosing-Week 78 Visit STARTED	505	0
Period 3: Week 54 Dosing-Week 78 Visit COMPLETED	474	0
Period 3: Week 54 Dosing-Week 78 Visit NOT COMPLETED	31	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-06438179 Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Infliximab-EU Remicade (INX) Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
Period 1: First Dose-Week 30 (Pre-dose) Death	2	2
Period 1: First Dose-Week 30 (Pre-dose) Lost to Follow-up	0	1
Period 1: First Dose-Week 30 (Pre-dose) Withdrawal by Subject	11	9
Period 1: First Dose-Week 30 (Pre-dose) Protocol Violation	5	1
Period 1: First Dose-Week 30 (Pre-dose) Insufficient clinical response	0	7
Period 1: First Dose-Week 30 (Pre-dose) Non-compliance with study treatment	1	0
Period 1: First Dose-Week 30 (Pre-dose) Pregnancy	2	0
Period 1: First Dose-Week 30 (Pre-dose) Adverse Event	18	20
Period 1: First Dose-Week 30 (Pre-dose) Other	4	0
Period 1: First Dose-Week 30 (Pre-dose) Randomized but not treated	1	0
Period 2: Week30 Dosing-Week54(Pre-dose) Death	1	0
Period 2: Week30 Dosing-Week54(Pre-dose) Adverse Event	22	9
Period 2: Week30 Dosing-Week54(Pre-dose) Other	3	0
Period 2: Week30 Dosing-Week54(Pre-dose) Non-compliance with study treatment	1	0
Period 2: Week30 Dosing-Week54(Pre-dose) Withdrawal by Subject	6	4
Period 2: Week30 Dosing-Week54(Pre-dose) Lost to Follow-up	1	1
Period 2: Week30 Dosing-Week54(Pre-dose) Insufficient clinical response	9	3
Period 3: Week 54 Dosing-Week 78 Visit Insufficient clinical response	3	0
Period 3: Week 54 Dosing-Week 78 Visit Adverse Event	14	0
Period 3: Week 54 Dosing-Week 78 Visit Other	4	0
Period 3: Week 54 Dosing-Week 78 Visit Non-compliance with study treatment	1	0
Period 3: Week 54 Dosing-Week 78 Visit Withdrawal by Subject	9	0

Baseline Characteristics

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-06438179 n=324 Participants Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Infliximab-EU Remicade (INX) n=326 Participants Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.	Total n=650 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 13.3 • n=5 Participants	52.8 years STANDARD_DEVIATION 12.9 • n=7 Participants	52.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	258 Participants n=5 Participants	264 Participants n=7 Participants	522 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	62 Participants n=7 Participants	128 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 14

Population: The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1	198 participants	207 participants	—

SECONDARY outcome

Timeframe: Week 2, 4, 6, 12, 22 and 30 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 Week 2	105 participants	121 participants	—
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 Week 4	170 participants	190 participants	—
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 Week 6	187 participants	201 participants	—
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 Week 12	210 participants	214 participants	—
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 week 22	205 participants	213 participants	—
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 Week 30 (pre-dose)	197 participants	209 participants	—

SECONDARY outcome

Timeframe: Week 38, 46 and 54 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 Week 38	206 participants	101 participants	110 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 Week 46	199 participants	98 participants	99 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 Week 54 (pre-dose)	199 participants	92 participants	101 participants

SECONDARY outcome

Timeframe: Week 62, 70 and 78

Population: The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 Week 62	199 participants	89 participants	103 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 Week 70	199 participants	87 participants	98 participants
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 Week 78	192 participants	86 participants	98 participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

ACR50 response: \>=50% improvement in tender joint count, \>=50% improvement in swollen joint count improvement and \>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \>=70% improvement in tender joint count, \>=70% improvement in swollen joint count improvement and \>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 2)	24 participants	24 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 4)	72 participants	59 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 6)	88 participants	80 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 12)	95 participants	101 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 14)	116 participants	108 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 22)	126 participants	116 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR50 (Week 30, pre-dose)	125 participants	132 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 2)	6 participants	6 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 4)	22 participants	13 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 6)	33 participants	16 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 12)	46 participants	40 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 14)	56 participants	33 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 22)	56 participants	45 participants	—
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 ACR70 (Week 30, pre-dose)	67 participants	58 participants	—

SECONDARY outcome

Timeframe: Week 38, 46 and 54 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR50 (Week 38)	132 participants	58 participants	75 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR50 (Week 46)	135 participants	55 participants	63 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR50 (Week 54, pre-dose)	135 participants	61 participants	65 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR70 (Week 38)	77 participants	33 participants	38 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR70 (Week 46)	75 participants	33 participants	33 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 ACR70 (Week 54, pre-dose)	82 participants	33 participants	35 participants

SECONDARY outcome

Timeframe: Week 62, 70 and 78

Population: The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR70 (Week 78)	98 participants	33 participants	44 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR50 (Week 62)	132 participants	59 participants	71 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR50 (Week 70)	142 participants	61 participants	67 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR50 (Week 78)	150 participants	57 participants	73 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR70 (Week 62)	88 participants	31 participants	41 participants
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 ACR70 (Week 70)	92 participants	35 participants	44 participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Population: The ITT Population was defined as all participants who were randomized to study treatment.

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale \[VAS\] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (\<)2.6=remission, \<3.2=low disease activity, \>=3.2-5.1=moderate disease activity and greater than (\>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Baseline)	5.950 units on a scale Standard Deviation 0.9577	5.983 units on a scale Standard Deviation 0.9210	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 2)	-1.213 units on a scale Standard Deviation 0.9280	-1.241 units on a scale Standard Deviation 0.8879	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 4)	-1.596 units on a scale Standard Deviation 1.1259	-1.605 units on a scale Standard Deviation 1.0881	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 6)	-1.710 units on a scale Standard Deviation 1.1959	-1.750 units on a scale Standard Deviation 1.0885	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 12)	-1.898 units on a scale Standard Deviation 1.3516	-1.885 units on a scale Standard Deviation 1.2142	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 14)	-1.901 units on a scale Standard Deviation 1.4125	-1.827 units on a scale Standard Deviation 1.3019	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 22)	-2.005 units on a scale Standard Deviation 1.4236	-2.002 units on a scale Standard Deviation 1.2972	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 DAS28-CRP (Change at Week 30)	-2.140 units on a scale Standard Deviation 1.4197	-2.117 units on a scale Standard Deviation 1.2738	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Baseline)	1.623 units on a scale Standard Deviation 0.6485	1.586 units on a scale Standard Deviation 0.6490	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 2)	-0.317 units on a scale Standard Deviation 0.4100	-0.328 units on a scale Standard Deviation 0.4370	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 4)	-0.472 units on a scale Standard Deviation 0.4728	-0.477 units on a scale Standard Deviation 0.4861	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 6)	-0.496 units on a scale Standard Deviation 0.5505	-0.520 units on a scale Standard Deviation 0.5022	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 12)	-0.535 units on a scale Standard Deviation 0.5795	-0.524 units on a scale Standard Deviation 0.5857	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 14)	-0.572 units on a scale Standard Deviation 0.5910	-0.531 units on a scale Standard Deviation 0.5876	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 22)	-0.588 units on a scale Standard Deviation 0.6061	-0.569 units on a scale Standard Deviation 0.5958	—
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 HAQ-DI (Change at Week 30)	-0.621 units on a scale Standard Deviation 0.6484	-0.612 units on a scale Standard Deviation 0.6546	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose), Week 38, 46 and 54

Population: The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter \[mm\]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \<2.6=remission, \<3.2=low disease activity, \>=3.2-5.1=moderate disease activity and \>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=278 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=142 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=141 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 DAS28-CRP (Change at Week 38)	-0.181 units on a scale Standard Deviation 0.9574	0.036 units on a scale Standard Deviation 0.8686	-0.059 units on a scale Standard Deviation 0.8756
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 DAS28-CRP (Baseline)	3.765 units on a scale Standard Deviation 1.4629	3.819 units on a scale Standard Deviation 1.3624	3.781 units on a scale Standard Deviation 1.2547
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 DAS28-CRP (Change at Week 46)	-0.228 units on a scale Standard Deviation 1.0453	0.048 units on a scale Standard Deviation 1.2584	-0.017 units on a scale Standard Deviation 1.0692
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 DAS28-CRP (Change at Week 54)	-0.275 units on a scale Standard Deviation 1.1338	-0.109 units on a scale Standard Deviation 1.1801	-0.057 units on a scale Standard Deviation 1.2339
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 HAQ-DI (Change at Baseline)	0.978 units on a scale Standard Deviation 0.7042	0.913 units on a scale Standard Deviation 0.6634	0.951 units on a scale Standard Deviation 0.6481
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 HAQ-DI (Change at Week 38)	-0.019 units on a scale Standard Deviation 0.3328	0.019 units on a scale Standard Deviation 0.2889	0.007 units on a scale Standard Deviation 0.3688
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 HAQ-DI (Change at Week 46)	-0.043 units on a scale Standard Deviation 0.3774	0.014 units on a scale Standard Deviation 0.3823	0.035 units on a scale Standard Deviation 0.4325
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 HAQ-DI (Change at Week 54)	-0.026 units on a scale Standard Deviation 0.4407	0.017 units on a scale Standard Deviation 0.4399	-0.044 units on a scale Standard Deviation 0.3881

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose), Week 62, 70 and 78

Population: The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \<2.6=remission, \<3.2=low disease activity, \>=3.2-5.1=moderate disease activity and \>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=249 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=123 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 DAS28-CRP (Baseline)	3.386 units on a scale Standard Deviation 1.3229	3.561 units on a scale Standard Deviation 1.3123	3.594 units on a scale Standard Deviation 1.2572
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 DAS28-CRP (Change at Week 62)	-0.072 units on a scale Standard Deviation 0.9150	-0.004 units on a scale Standard Deviation 0.8190	-0.154 units on a scale Standard Deviation 0.6840
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 DAS28-CRP (Change at Week 70)	-0.157 units on a scale Standard Deviation 0.9502	-0.168 units on a scale Standard Deviation 0.8421	-0.162 units on a scale Standard Deviation 0.7970
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 DAS28-CRP (Change at Week 78)	-0.236 units on a scale Standard Deviation 1.0361	-0.269 units on a scale Standard Deviation 0.9759	-0.215 units on a scale Standard Deviation 1.0584
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 HAQ-DI (Baseline)	0.905 units on a scale Standard Deviation 0.7050	0.893 units on a scale Standard Deviation 0.6691	0.883 units on a scale Standard Deviation 0.6109
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 HAQ-DI (Change at Week 62)	-0.024 units on a scale Standard Deviation 0.3126	0.021 units on a scale Standard Deviation 0.2989	0.008 units on a scale Standard Deviation 0.2942
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 HAQ-DI (Change at Week 70)	-0.046 units on a scale Standard Deviation 0.3502	-0.027 units on a scale Standard Deviation 0.2758	0.030 units on a scale Standard Deviation 0.2950
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 HAQ-DI (Change at Week 78)	-0.079 units on a scale Standard Deviation 0.3869	-0.022 units on a scale Standard Deviation 0.3521	0.001 units on a scale Standard Deviation 0.3800

SECONDARY outcome

Timeframe: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=\<) 1 or the score on the simplified disease activity index (SDAI) was =\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \<3.2: low disease activity, DAS28 \<2.6: remission.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 2)	2 participants	3 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 4)	10 participants	11 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 6)	12 participants	10 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 12)	28 participants	17 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 14)	27 participants	22 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 22)	25 participants	20 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 ACR/EULAR remission (Week 30, pre-dose)	30 participants	23 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 2)	9 participants	17 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 4)	28 participants	32 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 6)	40 participants	35 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 12)	52 participants	44 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 14)	53 participants	43 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 22)	58 participants	50 participants	—
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 DAS remission (Week 30, pre-dose)	62 participants	54 participants	—

SECONDARY outcome

Timeframe: Week 38, 46 and 54 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =\<1 or the score on the SDAI was =\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \<3.2: low disease activity, DAS28 \<2.6: remission.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 ACR/EULAR remission (Week 38)	29 participants	15 participants	8 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 ACR/EULAR remission (Week 46)	39 participants	15 participants	7 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 ACR/EULAR remission (Week 54, pre-dose)	42 participants	18 participants	13 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 DAS remission (Week 38)	74 participants	26 participants	25 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 DAS remission (Week 46)	76 participants	30 participants	21 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 DAS remission (Week 54, pre-dose)	79 participants	33 participants	29 participants

SECONDARY outcome

Timeframe: Week 62, 70 and 78

Population: The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 DAS remission (Week 78)	94 participants	39 participants	41 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 ACR/EULAR remission (Week 62)	46 participants	19 participants	20 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 ACR/EULAR remission (Week 70)	50 participants	18 participants	19 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 ACR/EULAR remission (Week 78)	57 participants	19 participants	18 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 DAS remission (Week 62)	85 participants	33 participants	34 participants
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 DAS remission (Week 70)	82 participants	40 participants	34 participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \>1.2 with DAS28 =\<3.2; moderate response = DAS28 change of \>0.6 to =\<1.2 with DAS28 \>3.2-5.1 and no-response = DAS28 change of =\<0.6 with DAS28 \>5.1.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=324 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 2 (good response)	24 participants	34 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 12 (good response)	90 participants	88 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 14 (good response)	97 participants	82 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 14 (moderate response)	137 participants	155 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 2 (moderate response)	172 participants	161 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 2 (no response)	121 participants	129 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 4 (good response)	61 participants	56 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 4 (moderate response)	162 participants	172 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 4 (no response)	89 participants	87 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 6 (good response)	65 participants	64 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 6 (moderate response)	168 participants	181 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 6 (no response)	79 participants	74 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 12 (moderate response)	149 participants	162 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 12 (no response)	71 participants	66 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 14 (no response)	76 participants	77 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 22 (good response)	103 participants	96 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 22 (moderate response)	125 participants	156 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 22 (no response)	73 participants	55 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 30 (good response)	101 participants	94 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 30 (moderate response)	133 participants	155 participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 Week 30 (no response)	58 participants	48 participants	—

SECONDARY outcome

Timeframe: Week 38, 46 and Week 54 (pre-dose)

Population: The ITT Population was defined as all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 38 (good response)	110 participants	51 participants	49 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 46 (good response)	107 participants	46 participants	49 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 46 (moderate response)	126 participants	64 participants	67 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 54 (no response)	29 participants	20 participants	16 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 38 (moderate response)	132 participants	62 participants	66 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 38 (no response)	34 participants	28 participants	25 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 46 (no response)	33 participants	28 participants	17 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 54 (good response)	118 participants	53 participants	50 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 Week 54 (moderate response)	109 participants	56 participants	62 participants

SECONDARY outcome

Timeframe: Week 62, 70 and Week 78

Population: The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 70 (moderate response)	92 participants	48 participants	54 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 70 (no response)	25 participants	15 participants	15 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 78 (good response)	133 participants	58 participants	57 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 78 (no response)	22 participants	11 participants	8 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 62 (good response)	122 participants	50 participants	57 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 62 (moderate response)	102 participants	56 participants	54 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 62 (no response)	25 participants	17 participants	13 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 70 (good response)	127 participants	56 participants	52 participants
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 Week 78 (moderate response)	84 participants	45 participants	53 participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=323 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 TEAEs	185 participants	176 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 SAEs	16 participants	20 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 Treatment related TEAEs	81 participants	75 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 Treatment related SAEs	4 participants	4 participants	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose) up to Week 54

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 TEAEs	103 participants	48 participants	54 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 SAEs	13 participants	11 participants	4 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 Treatment related TEAEs	32 participants	20 participants	16 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 Treatment related SAEs	2 participants	5 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose) up to Week 78

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 TEAEs	73 participants	38 participants	37 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 SAEs	3 participants	3 participants	6 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 Treatment related TEAEs	22 participants	10 participants	8 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 Treatment related SAEs	0 participants	1 participants	3 participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=323 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 TEAEs (Grade 3)	34 participants	34 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 TEAEs (Grade 4)	1 participants	6 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 TEAEs (Grade 5)	2 participants	1 participants	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose) up to Week 54

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 TEAEs (Grade 3)	17 participants	10 participants	6 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 TEAEs (Grade 4)	3 participants	3 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 TEAEs (Grade 5)	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose) up to Week 78

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 TEAEs (Grade 3)	4 participants	3 participants	7 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 TEAEs (Grade 4)	1 participants	0 participants	0 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 TEAEs (Grade 5)	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

Population: Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \<0.8\*lower limit of normal (LLN); platelets: \>1.75\*upper limit of normal (ULN); white blood cell count: \<0.6\*LLN; basophils, eosinophils, monocytes: \>1.2\*ULN. liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=321 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=325 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Laboratory Abnormalities: Period 1	245 participants	237 participants	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose) up to Week 54

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=279 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=142 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=141 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Laboratory Abnormalities: Period 2	154 participants	83 participants	63 participants

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose) up to Week 78

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=250 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=123 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Laboratory Abnormalities: Period 3	127 participants	72 participants	61 participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30

Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=321 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=325 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 4)	-7.8 joints Standard Deviation 7.75	-7.9 joints Standard Deviation 7.39	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 6)	-8.6 joints Standard Deviation 7.99	-9.0 joints Standard Deviation 7.92	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 12)	-9.6 joints Standard Deviation 8.61	-9.6 joints Standard Deviation 8.39	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 14)	-9.3 joints Standard Deviation 8.87	-9.6 joints Standard Deviation 8.44	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 22)	-10.5 joints Standard Deviation 8.77	-10.2 joints Standard Deviation 7.94	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 30)	-11.0 joints Standard Deviation 9.33	-10.7 joints Standard Deviation 8.52	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Baseline)	24.7 joints Standard Deviation 13.90	25.8 joints Standard Deviation 12.89	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 2)	-5.9 joints Standard Deviation 8.78	-7.5 joints Standard Deviation 8.39	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 4)	-9.5 joints Standard Deviation 10.02	-10.4 joints Standard Deviation 9.41	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 6)	-10.6 joints Standard Deviation 11.17	-12.1 joints Standard Deviation 10.12	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 12)	-12.1 joints Standard Deviation 11.84	-13.2 joints Standard Deviation 11.51	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 14)	-11.8 joints Standard Deviation 12.50	-13.0 joints Standard Deviation 12.15	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 22)	-13.2 joints Standard Deviation 12.62	-15.2 joints Standard Deviation 12.93	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Tender joint count (Change at Week 30)	-14.4 joints Standard Deviation 13.19	-15.6 joints Standard Deviation 12.57	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Baseline)	16.1 joints Standard Deviation 9.44	16.3 joints Standard Deviation 8.70	—
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Swollen joint count (Change at Week 2)	-5.5 joints Standard Deviation 6.89	-5.7 joints Standard Deviation 7.27	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose), Week 38, 46 and Week 54

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=278 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=142 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=141 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Tender joint count (Baseline)	10.2 joints Standard Deviation 11.74	10.2 joints Standard Deviation 11.96	9.1 joints Standard Deviation 8.89
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Tender joint count (Change at Week 38)	-1.3 joints Standard Deviation 6.74	-0.5 joints Standard Deviation 8.86	-1.0 joints Standard Deviation 6.03
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Tender joint count (Change at Week 46)	-1.6 joints Standard Deviation 7.87	-1.0 joints Standard Deviation 9.32	-0.8 joints Standard Deviation 7.77
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Tender joint count (Change at Week 54)	-1.7 joints Standard Deviation 7.96	-1.7 joints Standard Deviation 10.23	-0.5 joints Standard Deviation 9.03
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Swollen joint count (Baseline)	4.9 joints Standard Deviation 6.46	5.3 joints Standard Deviation 6.57	4.6 joints Standard Deviation 5.35
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Swollen joint count (Change at Week 38)	-0.8 joints Standard Deviation 4.19	-0.1 joints Standard Deviation 4.90	-0.3 joints Standard Deviation 3.93
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Swollen joint count (Change at Week 46)	-1.2 joints Standard Deviation 5.20	0.0 joints Standard Deviation 5.54	-0.5 joints Standard Deviation 4.22
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 Swollen joint count (Change at Week 54)	-1.3 joints Standard Deviation 5.52	-0.9 joints Standard Deviation 7.02	-0.7 joints Standard Deviation 4.10

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=249 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=123 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Swollen joint count (Change at Week 78)	-0.9 joints Standard Deviation 4.63	-0.5 joints Standard Deviation 4.00	-0.2 joints Standard Deviation 3.14
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Tender joint count (Baseline)	7.5 joints Standard Deviation 9.51	7.5 joints Standard Deviation 9.21	7.4 joints Standard Deviation 7.99
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Tender joint count (Change at Week 62)	-0.7 joints Standard Deviation 5.88	0.3 joints Standard Deviation 5.21	-0.8 joints Standard Deviation 5.18
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Tender joint count (Change at Week 70)	-1.4 joints Standard Deviation 6.32	-0.6 joints Standard Deviation 5.14	-1.0 joints Standard Deviation 5.51
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Tender joint count (Change at Week 78)	-1.7 joints Standard Deviation 6.57	-1.0 joints Standard Deviation 5.82	-1.4 joints Standard Deviation 6.63
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Swollen joint count (Baseline)	3.4 joints Standard Deviation 5.72	4.1 joints Standard Deviation 5.16	3.5 joints Standard Deviation 4.28
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Swollen joint count (Change at Week 62)	-0.3 joints Standard Deviation 3.76	0.0 joints Standard Deviation 4.41	-0.3 joints Standard Deviation 2.72
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 Swollen joint count (Change at Week 70)	-0.7 joints Standard Deviation 4.60	-0.4 joints Standard Deviation 4.12	-0.5 joints Standard Deviation 2.48

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=321 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=325 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Baseline)	63.514 units on a scale Standard Deviation 20.5903	63.098 units on a scale Standard Deviation 21.5442	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 2)	-15.724 units on a scale Standard Deviation 21.9589	-15.360 units on a scale Standard Deviation 19.4328	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 4)	-21.609 units on a scale Standard Deviation 22.3825	-20.552 units on a scale Standard Deviation 21.2670	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 6)	-23.917 units on a scale Standard Deviation 25.0213	-22.797 units on a scale Standard Deviation 22.9133	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 12)	-25.364 units on a scale Standard Deviation 25.6602	-25.829 units on a scale Standard Deviation 24.8304	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 14)	-26.131 units on a scale Standard Deviation 26.8712	-25.077 units on a scale Standard Deviation 25.0536	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at week 22)	-27.844 units on a scale Standard Deviation 27.0039	-25.788 units on a scale Standard Deviation 25.3225	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PAAP (Change at Week 30)	-29.150 units on a scale Standard Deviation 27.9802	-28.853 units on a scale Standard Deviation 26.7252	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Baseline)	65.340 units on a scale Standard Deviation 20.7209	63.752 units on a scale Standard Deviation 22.9105	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 2)	-17.262 units on a scale Standard Deviation 22.8767	-16.504 units on a scale Standard Deviation 20.3188	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 4)	-23.393 units on a scale Standard Deviation 23.3769	-21.355 units on a scale Standard Deviation 23.6005	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 6)	-25.536 units on a scale Standard Deviation 24.8041	-23.314 units on a scale Standard Deviation 24.2005	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 12)	-26.882 units on a scale Standard Deviation 25.3270	-26.535 units on a scale Standard Deviation 26.3998	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 14)	-27.583 units on a scale Standard Deviation 26.7955	-25.323 units on a scale Standard Deviation 26.8562	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 22)	-28.558 units on a scale Standard Deviation 27.5077	-26.486 units on a scale Standard Deviation 26.7141	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGA (Change at Week 30)	-29.186 units on a scale Standard Deviation 28.6488	-28.814 units on a scale Standard Deviation 28.5929	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Baseline)	65.362 units on a scale Standard Deviation 16.2520	64.126 units on a scale Standard Deviation 16.7220	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 2)	-21.913 units on a scale Standard Deviation 18.5574	-20.143 units on a scale Standard Deviation 17.1407	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 4)	-29.724 units on a scale Standard Deviation 19.2226	-27.905 units on a scale Standard Deviation 17.9803	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 6)	-33.319 units on a scale Standard Deviation 20.1143	-30.958 units on a scale Standard Deviation 18.9303	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 12)	-34.827 units on a scale Standard Deviation 19.8162	-33.919 units on a scale Standard Deviation 19.7020	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 14)	-35.870 units on a scale Standard Deviation 21.4707	-34.175 units on a scale Standard Deviation 20.6526	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 22)	-37.542 units on a scale Standard Deviation 20.8619	-36.118 units on a scale Standard Deviation 20.6564	—
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 PGAA (Change at Week 30)	-39.842 units on a scale Standard Deviation 22.0276	-36.666 units on a scale Standard Deviation 22.1598	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose), Week 38, 46 and 54

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=278 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=142 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=141 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PAAP (Baseline)	33.137 units on a scale Standard Deviation 24.2922	33.331 units on a scale Standard Deviation 22.2738	32.559 units on a scale Standard Deviation 22.2702
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PAAP (Change at Week 38)	-0.014 units on a scale Standard Deviation 18.7502	1.440 units on a scale Standard Deviation 14.9902	-0.705 units on a scale Standard Deviation 18.9147
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PAAP (Change at Week 46)	-2.230 units on a scale Standard Deviation 20.0201	1.087 units on a scale Standard Deviation 21.5811	2.188 units on a scale Standard Deviation 20.7319
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PAAP (Change at Week 54)	-1.416 units on a scale Standard Deviation 20.7823	-0.492 units on a scale Standard Deviation 20.8000	1.365 units on a scale Standard Deviation 24.8362
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGA (Baseline)	35.104 units on a scale Standard Deviation 24.8444	33.268 units on a scale Standard Deviation 22.2621	34.029 units on a scale Standard Deviation 22.7172
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGA (Change at Week 38)	-1.628 units on a scale Standard Deviation 19.1471	1.582 units on a scale Standard Deviation 16.0776	-1.086 units on a scale Standard Deviation 17.5787
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGA (Change at Week 46)	-3.171 units on a scale Standard Deviation 20.3050	0.558 units on a scale Standard Deviation 20.6610	0.535 units on a scale Standard Deviation 21.3947
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGA (Change at Week 54)	-2.929 units on a scale Standard Deviation 20.9396	-0.538 units on a scale Standard Deviation 21.1331	0.776 units on a scale Standard Deviation 23.8743
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGAA (Baseline)	25.124 units on a scale Standard Deviation 19.0943	27.294 units on a scale Standard Deviation 18.8148	26.091 units on a scale Standard Deviation 17.9503
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGAA (Change at Week 38)	-1.254 units on a scale Standard Deviation 12.4789	0.588 units on a scale Standard Deviation 16.5232	-1.852 units on a scale Standard Deviation 15.4699
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGAA (Change at Week 46)	-2.470 units on a scale Standard Deviation 13.9135	0.625 units on a scale Standard Deviation 20.0163	-0.700 units on a scale Standard Deviation 18.8038
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 PGAA (Change at Week 54)	-2.252 units on a scale Standard Deviation 17.0422	-3.398 units on a scale Standard Deviation 20.0381	-2.969 units on a scale Standard Deviation 20.1498

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=249 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=123 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PAAP (Baseline)	30.395 units on a scale Standard Deviation 23.7412	31.659 units on a scale Standard Deviation 23.2900	31.225 units on a scale Standard Deviation 22.9366
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PAAP (Change at Week 62)	-0.025 units on a scale Standard Deviation 15.8259	0.276 units on a scale Standard Deviation 12.2744	-1.790 units on a scale Standard Deviation 16.6740
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PAAP (Change at Week 70)	-2.948 units on a scale Standard Deviation 18.1105	-0.297 units on a scale Standard Deviation 15.4108	-0.970 units on a scale Standard Deviation 16.7170
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PAAP (Change at Week 78)	-3.552 units on a scale Standard Deviation 18.8760	-2.900 units on a scale Standard Deviation 18.0663	-3.918 units on a scale Standard Deviation 20.9632
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGA (Baseline)	30.841 units on a scale Standard Deviation 23.7807	31.130 units on a scale Standard Deviation 23.3603	32.710 units on a scale Standard Deviation 22.6365
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGA (Change at Week 62)	0.240 units on a scale Standard Deviation 16.2724	1.463 units on a scale Standard Deviation 13.6899	-2.226 units on a scale Standard Deviation 15.3415
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGA (Change at Week 70)	-1.764 units on a scale Standard Deviation 18.7038	0.101 units on a scale Standard Deviation 14.4260	-2.093 units on a scale Standard Deviation 16.2677
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGA (Change at Week 78)	-2.880 units on a scale Standard Deviation 19.6643	-2.339 units on a scale Standard Deviation 17.0453	-3.758 units on a scale Standard Deviation 19.5447
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGAA (Baseline)	21.305 units on a scale Standard Deviation 17.6278	21.780 units on a scale Standard Deviation 17.3354	20.705 units on a scale Standard Deviation 16.9587
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGAA (Change at Week 62)	-0.381 units on a scale Standard Deviation 13.6810	2.659 units on a scale Standard Deviation 14.6314	-0.499 units on a scale Standard Deviation 12.9483
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGAA (Change at Week 70)	-3.217 units on a scale Standard Deviation 14.1581	-1.160 units on a scale Standard Deviation 12.7665	-0.810 units on a scale Standard Deviation 15.0274
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 PGAA (Change at Week 78)	-2.217 units on a scale Standard Deviation 15.3894	0.681 units on a scale Standard Deviation 15.0989	-0.159 units on a scale Standard Deviation 17.2024

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=321 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=325 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Baseline	25.916 milligram/litres Standard Deviation 24.3118	25.366 milligram/litres Standard Deviation 28.4866	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 2	-17.183 milligram/litres Standard Deviation 20.8107	-16.140 milligram/litres Standard Deviation 24.2442	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 4	-15.555 milligram/litres Standard Deviation 19.5227	-13.407 milligram/litres Standard Deviation 33.9136	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 6	-14.078 milligram/litres Standard Deviation 20.4984	-13.247 milligram/litres Standard Deviation 27.7801	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 12	-12.502 milligram/litres Standard Deviation 23.9435	-12.525 milligram/litres Standard Deviation 27.8736	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 14	-12.613 milligram/litres Standard Deviation 23.2548	-12.392 milligram/litres Standard Deviation 29.3267	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 22	-11.195 milligram/litres Standard Deviation 24.5225	-11.422 milligram/litres Standard Deviation 31.0610	—
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 Change at Week 30	-12.165 milligram/litres Standard Deviation 25.6612	-12.390 milligram/litres Standard Deviation 30.0352	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose), Week 38, 46 and 54

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=278 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=142 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=141 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 Baseline	12.970 milligrams/litres Standard Deviation 19.1927	14.427 milligrams/litres Standard Deviation 21.1595	10.847 milligrams/litres Standard Deviation 14.8018
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 Change at Week 38	0.496 milligrams/litres Standard Deviation 18.7859	1.805 milligrams/litres Standard Deviation 19.5138	0.093 milligrams/litres Standard Deviation 14.8441
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 Change at Week 46	1.210 milligrams/litres Standard Deviation 16.1727	3.996 milligrams/litres Standard Deviation 24.4986	0.798 milligrams/litres Standard Deviation 15.7687
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 Change at Week 54	0.639 milligrams/litres Standard Deviation 21.1226	2.988 milligrams/litres Standard Deviation 24.5492	1.264 milligrams/litres Standard Deviation 13.6788

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose), Week 62, 70 and 78

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=249 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=123 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 Baseline	13.112 milligrams/litres Standard Deviation 21.3781	16.096 milligrams/litres Standard Deviation 24.1595	11.985 milligrams/litres Standard Deviation 13.8159
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 Change at Week 62	-0.635 milligrams/litres Standard Deviation 19.9660	-3.648 milligrams/litres Standard Deviation 21.6177	-0.541 milligrams/litres Standard Deviation 9.3198
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 Change at Week 70	-0.320 milligrams/litres Standard Deviation 23.1234	-4.199 milligrams/litres Standard Deviation 22.3368	-0.339 milligrams/litres Standard Deviation 11.7095
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 Change at Week 78	-1.660 milligrams/litres Standard Deviation 19.6340	-3.565 milligrams/litres Standard Deviation 23.9800	0.811 milligrams/litres Standard Deviation 14.7061

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 30

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=323 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 ADA	157 participants	167 participants	—
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 NAb	124 participants	143 participants	—

SECONDARY outcome

Timeframe: Baseline (Week 30 pre-dose) up to Week 54

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 ADA	146 participants	86 participants	83 participants
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 NAb	118 participants	73 participants	65 participants

SECONDARY outcome

Timeframe: Baseline (Week 54 pre-dose) up to Week 78

Population: Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.

ADA positive results was defined as ADA titer level \>=1.30 and NAb positive was defined as NAb titer level \>=0.70.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 ADA	119 participants	66 participants	72 participants
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 NAb	105 participants	58 participants	60 participants

SECONDARY outcome

Timeframe: Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29

Population: Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=323 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Serum Concentration Versus Time Summary: Period 1 Day 1 (0 hours)	1635 nanograms/milliliters Standard Deviation 11163	656.2 nanograms/milliliters Standard Deviation 6583.8	—
Serum Concentration Versus Time Summary: Period 1 Day 1 (2 hours)	65310 nanograms/milliliters Standard Deviation 24920	62220 nanograms/milliliters Standard Deviation 22129	—
Serum Concentration Versus Time Summary: Period 1 Day 15 (0 hours)	17350 nanograms/milliliters Standard Deviation 8391.4	16690 nanograms/milliliters Standard Deviation 8002.7	—
Serum Concentration Versus Time Summary: Period 1 Day 29 (336 hours)	23640 nanograms/milliliters Standard Deviation 12357	21570 nanograms/milliliters Standard Deviation 10986	—
Serum Concentration Versus Time Summary: Period 1 Day 43 (0 hours)	11440 nanograms/milliliters Standard Deviation 10101	10100 nanograms/milliliters Standard Deviation 7721.7	—
Serum Concentration Versus Time Summary: Period 1 Day 99 (0 hours)	3547 nanograms/milliliters Standard Deviation 9559.2	2559 nanograms/milliliters Standard Deviation 6360.3	—
Serum Concentration Versus Time Summary: Period 1 Day 99 (2 hours)	76030 nanograms/milliliters Standard Deviation 39407	73350 nanograms/milliliters Standard Deviation 41410	—
Serum Concentration Versus Time Summary: Period 1 Day 155 (0 hours)	2051 nanograms/milliliters Standard Deviation 3440.9	1566 nanograms/milliliters Standard Deviation 2321.4	—
Serum Concentration Versus Time Summary: Period 1 Day 211 (0 hours)	1781 nanograms/milliliters Standard Deviation 2765.2	2112 nanograms/milliliters Standard Deviation 11703	—

SECONDARY outcome

Timeframe: Pre dose on Day 211, 267, 379 and 547

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=280 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=143 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=143 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Serum Concentration Versus Time Summary: Period 2 Day 379 (0 hours)	2075 nanograms/milliliters Standard Deviation 4054.6	1823 nanograms/milliliters Standard Deviation 6110.8	1734 nanograms/milliliters Standard Deviation 2725.2
Serum Concentration Versus Time Summary: Period 2 Day 211 (0 hours)	1801 nanograms/milliliters Standard Deviation 2773.4	1083 nanograms/milliliters Standard Deviation 1763.6	1819 nanograms/milliliters Standard Deviation 2393.5
Serum Concentration Versus Time Summary: Period 2 Day 267 (0 hours)	1855 nanograms/milliliters Standard Deviation 2871.7	1208 nanograms/milliliters Standard Deviation 1926.5	1620 nanograms/milliliters Standard Deviation 2413.7
Serum Concentration Versus Time Summary: Period 2 Day 547 (0 hours)	499.6 nanograms/milliliters Standard Deviation 1373.0	212.7 nanograms/milliliters Standard Deviation 405.18	3305 nanograms/milliliters Standard Deviation 8429.5

SECONDARY outcome

Timeframe: Pre dose on Day 379, 435 and 547

Outcome measures

Outcome measures
Measure	Period 1: PF-06438179 n=253 Participants Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=126 Participants Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: INX/PF-06438179 n=126 Participants Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Serum Concentration Versus Time Summary: Period 3 Day 379 (0 hours)	2078 nanograms/milliliters Standard Deviation 4044.0	1823 nanograms/milliliters Standard Deviation 6110.8	1734 nanograms/milliliters Standard Deviation 2725.2
Serum Concentration Versus Time Summary: Period 3 Day 435 (0 hours)	1913 nanograms/milliliters Standard Deviation 2838.0	1388 nanograms/milliliters Standard Deviation 2387.4	1572 nanograms/milliliters Standard Deviation 2543.4
Serum Concentration Versus Time Summary: Period 3 Day 547	1707 nanograms/milliliters Standard Deviation 2512.9	1663 nanograms/milliliters Standard Deviation 5305.7	1482 nanograms/milliliters Standard Deviation 2441.6

Adverse Events

Period 1: PF-06438179

Serious events: 16 serious events

Other events: 38 other events

Deaths: 0 deaths

Period 1: Infliximab-EU Remicade (INX)

Serious events: 20 serious events

Other events: 35 other events

Deaths: 0 deaths

Period 2: PF-06438179/PF-06438179

Serious events: 13 serious events

Other events: 8 other events

Deaths: 0 deaths

Period 2: INX/INX

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Period 2: INX/PF-06438179

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Period 3: PF-06438179/PF-06438179/PF-06438179

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3: INX/INX/PF-06438179

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 3: INX/PF-06438179/PF-06438179

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Period 1: PF-06438179 n=323 participants at risk Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 participants at risk Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: PF-06438179/PF-06438179 n=280 participants at risk Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 2: INX/INX n=143 participants at risk Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 2: INX/PF-06438179 n=143 participants at risk Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 3: PF-06438179/PF-06438179/PF-06438179 n=253 participants at risk Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Period 3: INX/INX/PF-06438179 n=126 participants at risk Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Period 3: INX/PF-06438179/PF-06438179 n=126 participants at risk Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Infections and infestations Bronchitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Acute myocardial infarction	0.62% 2/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Angina unstable	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.61% 2/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Atrial flutter	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Coronary artery disease	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Cardiac disorders Myocardial infarction	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.40% 1/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Eye disorders Keratitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Diverticular perforation	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
General disorders Chest pain	0.62% 2/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
General disorders Multi-organ disorder	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
General disorders Systemic inflammatory response syndrome	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Cellulitis	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Diverticulitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Gastroenteritis norovirus	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Localised infection	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Peritonitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumocystis jirovecii pneumonia	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pneumonia	0.62% 2/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.61% 2/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Purulent synovitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Pyelonephritis acute	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Subcutaneous abscess	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Tuberculosis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Contusion	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Patella fracture	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	1.4% 2/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Transient ischaemic attack	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.31% 1/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Vascular disorders Shock	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Vascular disorders Venous stenosis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.31% 1/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Blood and lymphatic system disorders Blood disorder	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Enteritis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
General disorders Pyrexia	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
General disorders Sudden cardiac death	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Hepatobiliary disorders Cholecystitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Immune system disorders Anaphylactic reaction	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Acute sinusitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Arthritis bacterial	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Clostridium difficile infection	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Helicobacter infection	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Investigations Hepatic enzyme increased	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular lymphoma	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Genital prolapse	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.36% 1/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.70% 1/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Bone abscess	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Chronic sinusitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Infections and infestations Encephalitis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.40% 1/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.40% 1/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Endometriosis	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.79% 1/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.

Other adverse events

Other adverse events
Measure	Period 1: PF-06438179 n=323 participants at risk Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 1: Infliximab-EU Remicade (INX) n=326 participants at risk Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.	Period 2: PF-06438179/PF-06438179 n=280 participants at risk Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 2: INX/INX n=143 participants at risk Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 2: INX/PF-06438179 n=143 participants at risk Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.	Period 3: PF-06438179/PF-06438179/PF-06438179 n=253 participants at risk Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Period 3: INX/INX/PF-06438179 n=126 participants at risk Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.	Period 3: INX/PF-06438179/PF-06438179 n=126 participants at risk Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 19/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	6.4% 21/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	2.9% 8/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	7.7% 11/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	4.2% 6/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
Investigations Alanine aminotransferase increased	5.9% 19/323 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	4.6% 15/326 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/280 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/143 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/253 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.	0.00% 0/126 • Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78 Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.

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