Trial Outcomes & Findings for A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (NCT NCT02207244)

NCT ID: NCT02207244

Last Updated: 2021-07-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

992 participants

Primary outcome timeframe

Week 16

Results posted on

2021-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo (Week 0 - 16) Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).	Guselkumab 100 mg (Week 0 - 16) Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.	Adalimumab (Week 0 - 16) Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.	Placebo Then Guselkumab 100 mg (Week 16 - 28) Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).	Guselkumab 100 mg (Week 16 - 28) Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.	Adalimumab (Week 16 - 28) Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.	Placebo Then Guselkumab 100 mg (Week 28 - 264) Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (\>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Guselkumab 100 mg (Week 28 - 264) Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab Then Guselkumab 100 mg (Week 28 - 264) Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab (After ACP) Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of \>=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.	Guselkumab Combined All participants who received guselkumab 100 mg subcutaneously q8w at Week 76 and thereafter through Week 252.
Placebo Controlled Period: Week 0-16 STARTED	248	496	248	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Treated	248	494	248	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 COMPLETED	233	478	237	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 NOT COMPLETED	15	18	11	0	0	0	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 STARTED	0	0	0	233	478	237	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 COMPLETED	0	0	0	227	470	228	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 NOT COMPLETED	0	0	0	6	8	9	0	0	0	0	0
Withdrawal and Re-treatment: Week 28-72 STARTED	0	0	0	0	0	0	227	470	220	8	0
Withdrawal and Re-treatment: Week 28-72 Nonresponders	0	0	0	0	0	0	80	95	112	0	0
Withdrawal and Re-treatment: Week 28-72 Responders at Week 28	0	0	0	0	0	0	0	375	0	0	0
Withdrawal and Re-treatment: Week 28-72 Responders at Week 28 and Withdrawn From Treatment	0	0	0	0	0	0	147	0	108	0	0
Withdrawal and Re-treatment: Week 28-72 COMPLETED	0	0	0	0	0	0	213	443	211	0	0
Withdrawal and Re-treatment: Week 28-72 NOT COMPLETED	0	0	0	0	0	0	14	27	9	8	0
Open-label Guselkumab: Week 72-264 STARTED	0	0	0	0	0	0	0	0	211	0	656
Open-label Guselkumab: Week 72-264 COMPLETED	0	0	0	0	0	0	0	0	173	0	554
Open-label Guselkumab: Week 72-264 NOT COMPLETED	0	0	0	0	0	0	0	0	38	0	102

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Week 0 - 16) Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).	Guselkumab 100 mg (Week 0 - 16) Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.	Adalimumab (Week 0 - 16) Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.	Placebo Then Guselkumab 100 mg (Week 16 - 28) Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).	Guselkumab 100 mg (Week 16 - 28) Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.	Adalimumab (Week 16 - 28) Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.	Placebo Then Guselkumab 100 mg (Week 28 - 264) Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (\>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Guselkumab 100 mg (Week 28 - 264) Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab Then Guselkumab 100 mg (Week 28 - 264) Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 36 and 44. Participants who were PASI 90 responders, received placebo matched to guselkumab SC injection q4w thereafter through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab (After ACP) Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of \>=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.	Guselkumab Combined All participants who received guselkumab 100 mg subcutaneously q8w at Week 76 and thereafter through Week 252.
Placebo Controlled Period: Week 0-16 Adverse Event	2	9	4	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Lack of Efficacy	4	0	2	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Lost to Follow-up	1	3	2	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Withdrawal by Subject	7	1	0	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Protocol Violation	1	3	1	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 Noncompliance	0	1	2	0	0	0	0	0	0	0	0
Placebo Controlled Period: Week 0-16 OTHER	0	1	0	0	0	0	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Adverse Event	0	0	0	0	3	2	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Lack of Efficacy	0	0	0	0	0	2	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Lost to Follow-up	0	0	0	1	2	2	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Withdrawal by Subject	0	0	0	3	3	2	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Protocol Violation	0	0	0	1	0	1	0	0	0	0	0
Placebo Crossover and ACP: Week 16-28 Other	0	0	0	1	0	0	0	0	0	0	0
Withdrawal and Re-treatment: Week 28-72 Adverse Event	0	0	0	0	0	0	1	5	3	2	0
Withdrawal and Re-treatment: Week 28-72 Pregnancy	0	0	0	0	0	0	0	2	0	0	0
Withdrawal and Re-treatment: Week 28-72 Lack of Efficacy	0	0	0	0	0	0	1	3	2	2	0
Withdrawal and Re-treatment: Week 28-72 Lost to Follow-up	0	0	0	0	0	0	2	7	0	2	0
Withdrawal and Re-treatment: Week 28-72 Withdrawal by Subject	0	0	0	0	0	0	2	7	2	2	0
Withdrawal and Re-treatment: Week 28-72 Protocol Violation	0	0	0	0	0	0	0	1	1	0	0
Withdrawal and Re-treatment: Week 28-72 Noncompliance	0	0	0	0	0	0	0	0	1	0	0
Withdrawal and Re-treatment: Week 28-72 Other	0	0	0	0	0	0	0	2	0	0	0
Withdrawal and Re-treatment: Week 28-72 Participants not retreated with guselkumab	0	0	0	0	0	0	8	0	0	0	0
Open-label Guselkumab: Week 72-264 Withdrawal by Subject	0	0	0	0	0	0	0	0	10	0	30
Open-label Guselkumab: Week 72-264 Lack of Efficacy	0	0	0	0	0	0	0	0	2	0	3
Open-label Guselkumab: Week 72-264 Lost to Follow-up	0	0	0	0	0	0	0	0	5	0	26
Open-label Guselkumab: Week 72-264 Adverse Event	0	0	0	0	0	0	0	0	12	0	21
Open-label Guselkumab: Week 72-264 Death	0	0	0	0	0	0	0	0	1	0	1
Open-label Guselkumab: Week 72-264 Other	0	0	0	0	0	0	0	0	8	0	19
Open-label Guselkumab: Week 72-264 Pregnancy	0	0	0	0	0	0	0	0	0	0	2

Baseline Characteristics

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=248 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=496 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5, and q2w thereafter through Week 15.	Adalimumab n=248 Participants Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Weeks 1, 3, 5 and thereafter through week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12.	Total n=992 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	234 Participants n=5 Participants	470 Participants n=7 Participants	237 Participants n=5 Participants	941 Participants n=4 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	23 Participants n=7 Participants	11 Participants n=5 Participants	43 Participants n=4 Participants
Age, Continuous	43.3 years STANDARD_DEVIATION 12.38 • n=5 Participants	43.7 years STANDARD_DEVIATION 12.23 • n=7 Participants	43.2 years STANDARD_DEVIATION 11.92 • n=5 Participants	43.5 years STANDARD_DEVIATION 12.18 • n=4 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	147 Participants n=7 Participants	78 Participants n=5 Participants	300 Participants n=4 Participants
Sex: Female, Male Male	173 Participants n=5 Participants	349 Participants n=7 Participants	170 Participants n=5 Participants	692 Participants n=4 Participants
Region of Enrollment Australia	13 Participants n=5 Participants	25 Participants n=7 Participants	13 Participants n=5 Participants	51 Participants n=4 Participants
Region of Enrollment Czech Republic	9 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment Poland	68 Participants n=5 Participants	133 Participants n=7 Participants	64 Participants n=5 Participants	265 Participants n=4 Participants
Region of Enrollment Russia	24 Participants n=5 Participants	51 Participants n=7 Participants	25 Participants n=5 Participants	100 Participants n=4 Participants
Region of Enrollment Canada	30 Participants n=5 Participants	67 Participants n=7 Participants	33 Participants n=5 Participants	130 Participants n=4 Participants
Region of Enrollment United States	49 Participants n=5 Participants	93 Participants n=7 Participants	48 Participants n=5 Participants	190 Participants n=4 Participants
Region of Enrollment Germany	22 Participants n=5 Participants	40 Participants n=7 Participants	22 Participants n=5 Participants	84 Participants n=4 Participants
Region of Enrollment Spain	10 Participants n=5 Participants	22 Participants n=7 Participants	11 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment Korea, Democratic People'S Republic Of	23 Participants n=5 Participants	51 Participants n=7 Participants	24 Participants n=5 Participants	98 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=496 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16	8.5 percentage of participants	84.1 percentage of participants

PRIMARY outcome

Timeframe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=496 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16	2.4 percentage of participants	70.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24	51.8 percentage of participants	31.5 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24	83.5 percentage of participants	64.9 percentage of participants

SECONDARY outcome

Timeframe: Week 24

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24	75.2 percentage of participants	54.8 percentage of participants

SECONDARY outcome

Timeframe: Through Week 48

Population: Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.

Outcome measures

Outcome measures
Measure	Placebo n=181 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=193 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response	35.4 Percentage of Participants	81.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=495 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group	-2.6 units on a scale Standard Deviation 6.85	-11.23 units on a scale Standard Deviation 6.82

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16	84.1 percentage of participants	67.7 percentage of participants

SECONDARY outcome

Timeframe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16	70.0 percentage of participants	46.8 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=496 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=248 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16	86.3 percentage of participants	68.5 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (\>=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=202 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=408 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group	10.9 percentage of participants	80.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.

The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=198 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=411 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group	-8.3 units on a scale Standard Deviation 23.67	-40.4 units on a scale Standard Deviation 26.52

SECONDARY outcome

Timeframe: Week 24

Population: PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.

Outcome measures

Outcome measures
Measure	Placebo n=410 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=200 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24	35.1 Percentage of participants	22.5 Percentage of participants

SECONDARY outcome

Timeframe: Through Week 72

Population: Population analyzed included PASI 90 responders at Week 28 and who were randomized at Week 28 and treated with guselkumab. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.

Outcome measures

Outcome measures
Measure	Placebo n=181 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=193 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response	11.5 percentage of participants	86 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=560 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=177 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved PASI 90 Response at Week 252	82.0 percentage of participants	79.1 percentage of participants

SECONDARY outcome

Timeframe: Week 252

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=560 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=177 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved PASI 75 Response at Week 252	93.4 percentage of participants	92.7 percentage of participants

SECONDARY outcome

Timeframe: Week 252

The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=559 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=177 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252	85.0 percentage of participants	83.1 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score \>1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=550 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=173 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252	71.1 percentage of participants	69.9 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score \>0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=460 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=145 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252	42.0 percentage of participants	36.6 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score \>0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=461 Participants Participants received placebo matched to guselkumab SC injection at Weeks 0, 4 and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15 to maintain the blind during PCP.	Guselkumab 100 mg n=145 Participants Participants received guselkumab 100 mg SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 then placebo matched to adalimumab (1 SC injection) at Weeks 1, 3, 5 and q2w thereafter through Week 15.
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252	31.0 percentage of participants	24.1 percentage of participants

Adverse Events

Placebo (Week 0 - 16)

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Guselkumab 100 mg (Week 0 - 16)

Serious events: 8 serious events

Other events: 125 other events

Deaths: 0 deaths

Adalimumab (Week 0 - 16)

Serious events: 6 serious events

Other events: 51 other events

Deaths: 0 deaths

Placebo Then Guselkumab 100 mg (Week 16 - 28)

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Guselkumab 100 mg (Week 16 - 28)

Serious events: 10 serious events

Other events: 63 other events

Deaths: 0 deaths

Adalimumab (Week 16 - 28)

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo Then Guselkumab 100 mg (Week 28 - 264)

Serious events: 36 serious events

Other events: 144 other events

Deaths: 0 deaths

Guselkumab 100 mg (Week 28 - 264)

Serious events: 66 serious events

Other events: 297 other events

Deaths: 0 deaths

Adalimumab Then Guselkumab 100 mg (Week 28 - 264)

Serious events: 36 serious events

Other events: 159 other events

Deaths: 0 deaths

Adalimumab (After ACP)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Week 0 - 16) n=248 participants at risk Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).	Guselkumab 100 mg (Week 0 - 16) n=494 participants at risk Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.	Adalimumab (Week 0 - 16) n=248 participants at risk Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.	Placebo Then Guselkumab 100 mg (Week 16 - 28) n=233 participants at risk Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).	Guselkumab 100 mg (Week 16 - 28) n=481 participants at risk Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.	Adalimumab (Week 16 - 28) n=240 participants at risk Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.	Placebo Then Guselkumab 100 mg (Week 28 - 264) n=229 participants at risk Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (\>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Guselkumab 100 mg (Week 28 - 264) n=473 participants at risk Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab Then Guselkumab 100 mg (Week 28 - 264) n=220 participants at risk Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 36 and q8w through Week 72. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 72 or until loss of \>=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252. The presentation of data from the adalimumab group from Week 28 to Week 264 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 264) and adalimumab (After ACP) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).	Adalimumab (After ACP) n=11 participants at risk Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of \>=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
Blood and lymphatic system disorders Anaemia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.85% 4/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Angina Pectoris	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Angina Unstable	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Atrial Fibrillation	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Bradycardia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Cardiac Failure	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Coronary Artery Disease	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Myocardial Infarction	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.91% 2/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Myocardial Ischaemia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Eye disorders Retinal Vein Occlusion	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Duodenal Perforation	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Gastritis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Haemorrhoids	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Irritable Bowel Syndrome	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Pancreatitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Submaxillary Gland Enlargement	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
General disorders Non-Cardiac Chest Pain	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
General disorders Sudden Death	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Hepatobiliary disorders Cholecystitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.91% 2/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Hepatobiliary disorders Cholecystitis Chronic	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Hepatobiliary disorders Cholelithiasis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.91% 2/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Immune system disorders Anaphylactic Reaction	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Immune system disorders Drug Hypersensitivity	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Appendicitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.85% 4/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Appendicitis Perforated	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Bronchitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Cellulitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.85% 4/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Chronic Sinusitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Chronic Tonsillitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Cystitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Disseminated Tuberculosis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Diverticulitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Erysipelas	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Hiv Infection	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Influenza	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Injection Site Abscess	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Peritonsillar Abscess	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Pilonidal Cyst	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Pneumonia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.91% 2/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Retroperitoneal Abscess	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Soft Tissue Infection	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Tuberculosis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Urosepsis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Vestibular Neuronitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Wound Infection	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Chest Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Concussion	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Eye Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Head Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Reproductive system and breast disorders Uterine Haemorrhage	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Ligament Rupture	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Nerve Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Spinal Cord Injury Cervical	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Subdural Haemorrhage	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Ulnar Nerve Injury	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Injury, poisoning and procedural complications Wound	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Investigations Alanine Aminotransferase Increased	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Metabolism and nutrition disorders Obesity	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.4% 3/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.63% 3/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm of Thyroid Gland	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of Breast	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory Pseudotumour	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Stage Iv	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal Papilloma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Cerebellar Stroke	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Diabetic Coma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Epilepsy	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Myelitis Transverse	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Myelopathy	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Paraesthesia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Peripheral Nerve Lesion	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Peripheral Nerve Paresis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Presyncope	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Syncope	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Product Issues Device Dislocation	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Psychiatric disorders Alcoholism	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Psychiatric disorders Anxiety	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Psychiatric disorders Depression	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Psychiatric disorders Suicide Attempt	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Renal and urinary disorders Nephrolithiasis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Renal and urinary disorders Renal Colic	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Renal and urinary disorders Ureterolithiasis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Renal and urinary disorders Urinary Retention	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Reproductive system and breast disorders Prostatitis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Sinus Polyp	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Social circumstances Miscarriage of Partner	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Vascular disorders Haematoma	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.44% 1/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Vascular disorders Hypertension	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Vascular disorders Varicose Vein	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.45% 1/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.

Other adverse events

Other adverse events
Measure	Placebo (Week 0 - 16) n=248 participants at risk Participants received placebo matched to guselkumab subcutaneous (SC) injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 SC injections) at Week 0, followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 to maintain the blind during placebo controlled period (PCP).	Guselkumab 100 mg (Week 0 - 16) n=494 participants at risk Participants received guselkumab 100 milligram (mg) SC injection at Weeks 0, 4 and 12, and placebo matched to adalimumab (2 SC injections) at Week 0 followed by placebo matched to adalimumab (1 SC injection) at Week 1 and every other week thereafter through Week 15 during PCP.	Adalimumab (Week 0 - 16) n=248 participants at risk Participants received adalimumab 80 mg (2 SC injections) at Week 0 followed by adalimumab 40 mg (1 SC injection) at Week 1 and every other week thereafter through Week 15 and placebo matched to guselkumab SC injection at Weeks 0, 4, and 12 during PCP.	Placebo Then Guselkumab 100 mg (Week 16 - 28) n=233 participants at risk Participants who started receiving placebo in the first period were crossed over to receive guselkumab 100 mg SC injection at Weeks 16 and 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21, and 23 during the active comparator controlled period (ACP).	Guselkumab 100 mg (Week 16 - 28) n=481 participants at risk Participants who started receiving guselkumab in the first period, received placebo matched to guselkumab SC injection at Week 16 followed by guselkumab 100 mg SC injection at Week 20 and placebo matched to adalimumab (1 SC injection) at Weeks 17, 19, 21 and 23.	Adalimumab (Week 16 - 28) n=240 participants at risk Participants who received adalimumab in the first period, continued to receive adalimumab 40 mg (1 SC injection) every 2 weeks (q2w) from Week 17 through Week 23 and placebo matched to guselkumab SC injection at Weeks 16 and 20.	Placebo Then Guselkumab 100 mg (Week 28 - 264) n=229 participants at risk Participants assigned to the placebo, then guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and then every 8 weeks (q8w) thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders at Week 28 received placebo matched to guselkumab SC injection at Week 28 and every 4 weeks (q4w) thereafter through Week 72 or until loss of greater than or equal to (\>=) 50 percentage (%) in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Guselkumab 100 mg (Week 28 - 264) n=473 participants at risk Participants assigned to the guselkumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders at Week 28 received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab at Week 32 and then q8w through Week 72. Participants who were PASI 90 responders were re-randomized to either guselkumab or placebo. Participants re-randomized to guselkumab, received guselkumab 100 mg SC injection at Week 28 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Weeks 32 and then q8w through Week 72. Participants re-randomized to placebo, received placebo matched to guselkumab SC injection q4w through Week 72 or until loss of \>=50% in the improvement in PASI (Withdrawal and retreatment period). If they lost response according to this definition, they were retreated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252.	Adalimumab Then Guselkumab 100 mg (Week 28 - 264) n=220 participants at risk Participants who were assigned to the adalimumab arm through Week 28 were assessed for PASI 90 response at Week 28. Participants who were PASI 90 non-responders received guselkumab 100 mg SC injection at Week 28 and 32 and q8w thereafter through Week 72 and placebo matched to guselkumab SC injection at Week 36 and q8w through Week 72. Participants who were PASI 90 responders, received placebo matched to guselkumab subcutaneous injection q4w thereafter through Week 72 or until loss of \>=50% in the improvement in PASI. If they lost response according to this definition, they were treated with guselkumab. Thereafter, participants received guselkumab 100 mg at Week 76 and then q8w through Week 252. The presentation of data from the adalimumab group from Week 28 to Week 264 is divided into 2 arms (adalimumab then guselkumab 100 mg (Week 28 - 264) and adalimumab (After ACP) in order to represent exposure to 2 different active study agents (adalimumab vs guselkumab).	Adalimumab (After ACP) n=11 participants at risk Participants who received adalimumab 80 mg at Week 0 and adalimumab 40 mg at Week 1 and every other week through Week 23 were assessed for PASI 90 response at Week 28. PASI 90 responders who did not crossover to guselkumab upon loss of \>=50% in the improvement in PASI and did not continue any treatment at Week 28 are reported in this arm.
Infections and infestations Bronchitis	1.2% 3/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.61% 3/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.0% 5/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.6% 6/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.62% 3/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.2% 3/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	6.6% 15/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.9% 23/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.5% 21/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Gastroenteritis	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.81% 4/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.0% 5/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.8% 11/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.4% 16/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.0% 11/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Diarrhoea	0.81% 2/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.2% 11/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.6% 4/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.62% 3/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.2% 3/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.8% 11/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.2% 15/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.5% 12/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 2/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.5% 12/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.8% 4/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Nasopharyngitis	6.5% 16/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.1% 35/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	8.1% 20/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.2% 12/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.7% 18/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	6.7% 16/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	29.3% 67/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	30.0% 142/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	36.8% 81/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Pharyngitis	0.81% 2/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.4% 7/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.86% 2/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.0% 5/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 2/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.9% 18/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	6.8% 32/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.3% 5/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Sinusitis	1.2% 3/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.61% 3/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.81% 2/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.62% 3/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 2/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.0% 16/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.9% 23/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.0% 11/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Upper Respiratory Tract Infection	4.0% 10/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.2% 16/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.6% 4/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.1% 5/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.5% 12/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.5% 6/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	17.0% 39/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	23.5% 111/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	22.3% 49/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Infections and infestations Viral Upper Respiratory Tract Infection	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.2% 6/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.1% 7/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.0% 19/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.5% 12/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Metabolism and nutrition disorders Hyperglycaemia	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 2/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.7% 4/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.9% 9/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.4% 3/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 6/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.2% 11/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.81% 2/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.7% 8/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.5% 6/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.4% 17/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.7% 46/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	10.0% 22/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Musculoskeletal and connective tissue disorders Back Pain	2.4% 6/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.81% 4/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.2% 6/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.9% 18/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.3% 25/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.3% 16/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Nervous system disorders Headache	2.8% 7/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.1% 25/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.0% 5/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.1% 5/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.2% 6/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.7% 4/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.9% 9/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	6.6% 31/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	7.7% 17/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 4/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.6% 8/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 2/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.4% 10/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	3.4% 16/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	5.9% 13/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.81% 2/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.81% 4/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.40% 1/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 2/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.87% 2/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.3% 11/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.7% 6/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Skin and subcutaneous tissue disorders Psoriasis	1.2% 3/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.0% 5/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.21% 1/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.3% 3/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	1.7% 8/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	4.1% 9/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 1/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.
Vascular disorders Hypertension	1.6% 4/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.0% 10/494 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	2.4% 6/248 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.43% 1/233 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.83% 4/481 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.42% 1/240 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	11.8% 27/229 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 43/473 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	9.1% 20/220 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.	0.00% 0/11 • Baseline (Week 0) up to Week 264 Safety analysis: all participants who were randomized at Week 0, received \>=1 dose of study agent (partial or complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in the previous period and had safety follow-up continuing in the current period, were counted in both the periods.

Additional Information

Senior Director

Janssen Research & Development, LLC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER