Trial Outcomes & Findings for Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab (NCT NCT03107793)

Last Updated: 2025-04-29

Results Overview

Endoscopic response defined as showing a reduction from baseline in simple endoscopic score for Crohn's disease (SES-CD) of greater than or equal to (\>=) 50 percent (%). SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to any reason, or participants without endoscopic data at Week 48 were analyzed as nonresponders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

500 participants

Primary outcome timeframe

Week 48

Results posted on

2025-04-29

Participant Flow

Out of 500 enrolled participants who received at least 1 dose of study medication, 498 participants were included in the analysis because study team decided to exclude one site due to compliance issue. Hence, number of participants who received at least one dose of study medication reduced from 500 to 498 participants.

Participant milestones

Participant milestones
Measure	Induction Period: Ustekinumab (6 Milligrams [mg]/Kilogram [kg]) Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either in treat to target arm or routine care arm.	Maintenance Period: Treat to Target Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.	Extension Period: Treat to Target From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.	Extension Period: Routine Care From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 mg/L and fecal calprotectin \<=250 mcg/g) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.
Induction Period (16 Weeks) STARTED	498	0	0	0	0
Induction Period (16 Weeks) Participants Who Entered the Maintenance Period	0	219	221	0	0
Induction Period (16 Weeks) Participants Who Entered the Extension Period	0	0	0	147	176
Induction Period (16 Weeks) COMPLETED	488	0	0	0	0
Induction Period (16 Weeks) NOT COMPLETED	10	0	0	0	0
Maintenance Period (Week 16-Week 48) STARTED	0	219	221	0	0
Maintenance Period (Week 16-Week 48) COMPLETED	0	173	193	0	0
Maintenance Period (Week 16-Week 48) NOT COMPLETED	0	46	28	0	0
Extension Period (Week 48- Week 104) STARTED	0	0	0	147	176
Extension Period (Week 48- Week 104) COMPLETED	0	0	0	119	139
Extension Period (Week 48- Week 104) NOT COMPLETED	0	0	0	28	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction Period: Ustekinumab (6 Milligrams [mg]/Kilogram [kg]) Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either in treat to target arm or routine care arm.	Maintenance Period: Treat to Target Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.	Extension Period: Treat to Target From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.	Extension Period: Routine Care From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 mg/L and fecal calprotectin \<=250 mcg/g) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.
Induction Period (16 Weeks) Adverse Event	5	0	0	0	0
Induction Period (16 Weeks) Physician Decision	1	0	0	0	0
Induction Period (16 Weeks) Progressive disease	1	0	0	0	0
Induction Period (16 Weeks) Withdrawal by Subject	3	0	0	0	0
Maintenance Period (Week 16-Week 48) Adverse Event	0	6	10	0	0
Maintenance Period (Week 16-Week 48) Physician Decision	0	1	2	0	0
Maintenance Period (Week 16-Week 48) Progressive disease	0	0	1	0	0
Maintenance Period (Week 16-Week 48) Lack of Efficacy	0	21	8	0	0
Maintenance Period (Week 16-Week 48) Death	0	2	0	0	0
Maintenance Period (Week 16-Week 48) Disease relapse	0	2	1	0	0
Maintenance Period (Week 16-Week 48) Lost to Follow-up	0	1	0	0	0
Maintenance Period (Week 16-Week 48) Pregnancy	0	1	1	0	0
Maintenance Period (Week 16-Week 48) Received a disallowed concomitant treatment	0	0	1	0	0
Maintenance Period (Week 16-Week 48) Withdrawal by Subject	0	12	4	0	0
Extension Period (Week 48- Week 104) Adverse Event	0	0	0	10	3
Extension Period (Week 48- Week 104) Physician Decision	0	0	0	0	2
Extension Period (Week 48- Week 104) Lack of Efficacy	0	0	0	8	9
Extension Period (Week 48- Week 104) Death	0	0	0	0	1
Extension Period (Week 48- Week 104) Disease relapse	0	0	0	0	3
Extension Period (Week 48- Week 104) Lost to Follow-up	0	0	0	1	2
Extension Period (Week 48- Week 104) Pregnancy	0	0	0	2	4
Extension Period (Week 48- Week 104) Did not re-consent to protocol amendment 3	0	0	0	0	1
Extension Period (Week 48- Week 104) Non-compliance with study drug	0	0	0	1	0
Extension Period (Week 48- Week 104) Other	0	0	0	1	3
Extension Period (Week 48- Week 104) Withdrawal by Subject	0	0	0	5	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction Period: Ustekinumab (6 Milligrams [mg]/Kilogram [kg]) n=498 Participants Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either in treat to target arm or routine care arm.
Age, Continuous	37 years STANDARD_DEVIATION 12.96 • n=498 Participants
Age, Customized 18-25 years	112 Participants n=498 Participants
Age, Customized 26-50 years	302 Participants n=498 Participants
Age, Customized 51-64 years	71 Participants n=498 Participants
Age, Customized >=65 years	13 Participants n=498 Participants
Sex: Female, Male Female	257 Participants n=498 Participants
Sex: Female, Male Male	241 Participants n=498 Participants
Region of Enrollment Belgium	29 Participants n=498 Participants
Region of Enrollment Czech Republic	24 Participants n=498 Participants
Region of Enrollment Denmark	15 Participants n=498 Participants
Region of Enrollment France	51 Participants n=498 Participants
Region of Enrollment Germany	26 Participants n=498 Participants
Region of Enrollment Italy	166 Participants n=498 Participants
Region of Enrollment Netherlands	19 Participants n=498 Participants
Region of Enrollment Portugal	37 Participants n=498 Participants
Region of Enrollment Slovakia	30 Participants n=498 Participants
Region of Enrollment Spain	47 Participants n=498 Participants
Region of Enrollment Sweden	15 Participants n=498 Participants
Region of Enrollment United Kingdom	39 Participants n=498 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Endoscopic Response at Week 48	37.9 Percentage of Participants 95% Confidence Interval 31.4 • Interval 31.4 to 44.7	29.9 Percentage of Participants 95% Confidence Interval 23.9 • Interval 23.9 to 36.4

SECONDARY outcome

Timeframe: Week 48

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'N' (Number of participants analyzed) included participants who were evaluable for this outcome measure.

Endoscopic response defined as showing a reduction from baseline in SES-CD (a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions) score of \>=50%. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is calculated as sum of 4 variables for 5 bowel segments. Scores ranges 0-60. Higher scores indicates more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to reasons other than lack/loss of efficacy were excluded from analysis.

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=193 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=198 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded)	43.0 Percentage of Participants 95% Confidence Interval 35.9 • Interval 35.9 to 50.3	32.3 Percentage of Participants 95% Confidence Interval 25.9 • Interval 25.9 to 39.3

SECONDARY outcome

Timeframe: Week 48 (LOCF)

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Endoscopic response defined as a reduction from baseline in SES-CD score of \>= 50%. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments. Scores range from 0 to 60, with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward.

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF])	40.2 Percentage of Participants 95% Confidence Interval 33.6 • Interval 33.6 to 47.0	30.8 Percentage of Participants 95% Confidence Interval 24.8 • Interval 24.8 to 37.3

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Clinical response defined as a \>=100-point reduction from the baseline in Crohn's Disease Activity Index (CDAI) score, or a CDAI score of \<150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-responder. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 16	84.5 Percentage of Participants Interval 80.0 to 89.8	89.6 Percentage of Participants Interval 84.8 to 93.3
Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 48	68.0 Percentage of Participants Interval 61.4 to 74.2	77.8 Percentage of Participants Interval 71.8 to 83.1
Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	89.5 Percentage of Participants Interval 84.7 to 93.2	89.6 Percentage of Participants Interval 84.8 to 93.3

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Clinical Remission defined as a CDAI score of \<150 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 16	72.1 Percentage of Participants Interval 65.7 to 78.0	74.2 Percentage of Participants Interval 67.9 to 79.8
Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 48	61.6 Percentage of Participants Interval 54.9 to 68.1	69.7 Percentage of Participants Interval 63.2 to 75.7
Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	77.2 Percentage of Participants Interval 71.0 to 82.6	78.3 Percentage of Participants Interval 72.3 to 83.5

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) refers participants analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis.

Percentage of participants with Endoscopic remission defined as SES-CD score \<=2 at Weeks 16, 48, and Endpoint (Week 48 \[LOCF\]) were reported. SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 16	11.4 Percentage of Participants Interval 7.5 to 16.4	—
Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 48	11.4 Percentage of Participants Interval 7.5 to 16.4	14.5 Percentage of Participants Interval 10.1 to 19.8
Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	11.9 Percentage of Participants Interval 7.9 to 16.9	15.4 Percentage of Participants Interval 10.9 to 20.8

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) is defined as number of participants who were analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis.

Mucosal healing is defined as the complete absence of mucosal ulcerations in any ileocolonic segment. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 16	16.0 Percentage of Participants Interval 11.4 to 21.5	—
Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 48	14.2 Percentage of Participants Interval 9.8 to 19.5	16.7 Percentage of Participants Interval 12.1 to 22.3
Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	14.6 Percentage of Participants Interval 10.2 to 20.0	17.6 Percentage of Participants Interval 12.9 to 23.3

SECONDARY outcome

Timeframe: Week 48 and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 \[LOCF\]) is defined as a CDAI score \<150 and not taking any corticosteroids for at least 30 days prior to Week 48 and Endpoint assessment. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were analyzed as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) Week 48	56.6 Percentage of Participants Interval 49.8 to 63.3	63.3 Percentage of Participants Interval 56.6 to 69.7
Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	70.8 Percentage of Participants Interval 64.3 to 76.7	69.7 Percentage of Participants Interval 63.2 to 75.7

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'n' (number analyzed) included participants analyzed at specified timepoints. Data was not collected for routine care arm at Week 16 as per planned analysis.

Corticosteroid-free endoscopic response defined as a reduction from baseline in SES-CD score of \>=50% and not taking any corticosteroids for at least 30 days prior to Weeks 16, 48 and endpoint (Week 48 \[LOCF\]). SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total score is sum of 4 variables. Scores range 0-60. Higher scores means severe disease. Participants with missing data were analyzed as No SES-CD Improvement. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e., first 48 weeks).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 16	26.5 Percentage of Participants Interval 20.8 to 32.9	—
Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Week 48	33.8 Percentage of Participants Interval 27.6 to 40.5	28.5 Percentage of Participants Interval 22.7 to 34.9
Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) Endpoint (Week 48 [LOCF])	36.1 Percentage of Participants Interval 29.7 to 42.8	29.4 Percentage of Participants Interval 23.5 to 35.9

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF]

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. Here, 'N' (Number analyzed) included participants who were evaluable for this outcome measure.

Change from baseline in serum CRP were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=218 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=219 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Serum C-reactive Protein (CRP) Change at Week 16	-7.717 Milligrams per liter (mg/L) Standard Deviation 22.0246	-7.345 Milligrams per liter (mg/L) Standard Deviation 17.5658
Change From Baseline in Serum C-reactive Protein (CRP) Change at Week 48	-7.839 Milligrams per liter (mg/L) Standard Deviation 22.6777	-7.909 Milligrams per liter (mg/L) Standard Deviation 22.2139
Change From Baseline in Serum C-reactive Protein (CRP) Change at Endpoint (Week 48 [LOCF])	-7.839 Milligrams per liter (mg/L) Standard Deviation 22.6777	-7.909 Milligrams per liter (mg/L) Standard Deviation 22.2139

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF])

Change from baseline in FC were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=196 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=189 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Fecal Calprotectin (FC) Change at Week 16	-988.8 Micrograms per gram (mcg/g) Standard Deviation 3243.61	-728.2 Micrograms per gram (mcg/g) Standard Deviation 2238.60
Change From Baseline in Fecal Calprotectin (FC) Change at Week 48	-1191.6 Micrograms per gram (mcg/g) Standard Deviation 3441.64	-744.4 Micrograms per gram (mcg/g) Standard Deviation 2589.30
Change From Baseline in Fecal Calprotectin (FC) Change at Endpoint (Week 48 [LOCF])	-1191.6 Micrograms per gram (mcg/g) Standard Deviation 3441.64	-744.4 Micrograms per gram (mcg/g) Standard Deviation 2589.30

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

IBDQ response was defined as \>= 16-point improvement in IBDQ total score from baseline. The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. Each item score ranged from 1 (worst possible response) to 7 (best possible response). Each items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e, first 48 weeks).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response Week 16	71.7 Percentage of Participants Interval 65.2 to 77.6	75.1 Percentage of Participants Interval 68.9 to 80.7
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response Week 48	58.4 Percentage of Participants Interval 51.6 to 65.0	67.0 Percentage of Participants Interval 60.3 to 73.1
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response Endpoint (Week 48 [LOCF])	77.2 Percentage of Participants Interval 71.0 to 82.6	77.8 Percentage of Participants Interval 71.8 to 83.1

SECONDARY outcome

Timeframe: Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Percentage of participants with 7-point change from baseline in WPAI scores for each domain were reported. WPAI is 6-item (7-day recall period) well-validated questionnaire to measure impairments in work and activities that produces 4 types of domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), activity impairment. Participants who answered first question of the questionnaire 'Are you currently employed' as 'Yes' were included in absenteeism, presenteeism, and work productivity. In activity impairment all participants were included. Each score range: 0-100, higher scores=greater impairment and less productivity. LOCF: Participants who had missing value at Week 48 or stopped treatment before reaching Week 48 had last non-missing value carried forward. Endpoint: last available postbaseline result in main analysis period (first 48 weeks).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=212 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=215 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 16: Absenteeism	34.9 Percentage of Participants Interval 24.9 to 45.9	39.6 Percentage of Participants Interval 29.7 to 50.1
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 48: Absenteeism	35.0 Percentage of Participants Interval 23.1 to 48.4	36.4 Percentage of Participants Interval 25.7 to 48.1
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Endpoint (Week 48 [LOCF]): Absenteeism	34.9 Percentage of Participants Interval 24.8 to 46.2	36.3 Percentage of Participants Interval 26.4 to 47.0
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 16: Presenteeism	70.5 Percentage of Participants Interval 60.8 to 79.0	76.9 Percentage of Participants Interval 67.6 to 84.6
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 48: Presenteeism	73.1 Percentage of Participants Interval 61.8 to 82.5	72.8 Percentage of Participants Interval 62.6 to 81.6
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Endpoint (Week 48 [LOCF]): Presenteeism	69.6 Percentage of Participants Interval 59.7 to 78.3	69.8 Percentage of Participants Interval 60.1 to 78.3
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 16: Work Productivity Loss	71.4 Percentage of Participants Interval 60.0 to 81.2	70.7 Percentage of Participants Interval 59.6 to 80.3
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 48: Work Productivity Loss	75.0 Percentage of Participants Interval 61.6 to 85.6	72.1 Percentage of Participants Interval 59.9 to 82.3
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Endpoint (Week 48 [LOCF]): Work Productivity Loss	72.4 Percentage of Participants Interval 60.9 to 82.0	69.6 Percentage of Participants Interval 58.2 to 79.5
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 16: Activity Impairment	72.1 Percentage of Participants Interval 65.4 to 78.1	78.3 Percentage of Participants Interval 72.0 to 83.7
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Week 48: Activity Impairment	74.4 Percentage of Participants Interval 66.8 to 81.0	71.9 Percentage of Participants Interval 64.7 to 78.4
Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain Endpoint (Week 48 [LOCF]): Activity Impairment	67.9 Percentage of Participants Interval 61.2 to 74.2	70.7 Percentage of Participants Interval 64.1 to 76.7

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

The IBDQ is 32-item questionnaire used to evaluate disease-specific health-related quality of life. Each item score ranged from 1 (worst possible response) to 7 (best possible response). Items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function with scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). Higher score, better quality of life. Total score is sum of each item score and ranges from 32 to 224. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (that is, first 48 weeks of the study). Only participants with non-missing baseline value and at least one non-missing post-baseline value during main treatment period were included in analysis.

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=214 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=217 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in IBDQ Score Change at Week 16	41.3 Units on a scale Standard Deviation 34.24	44.7 Units on a scale Standard Deviation 33.20
Change From Baseline in IBDQ Score Change at Week 48	43.7 Units on a scale Standard Deviation 35.16	44.3 Units on a scale Standard Deviation 36.94
Change From Baseline in IBDQ Score Change at Endpoint (Week 48 [LOCF])	43.7 Units on a scale Standard Deviation 35.16	44.3 Units on a scale Standard Deviation 36.94

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

EQ-5D-5L, validated quality-of-life instrument completed by participants. It consists of EQ-5D-5L descriptive system and EQ-VAS. EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) describes participants current health state. Each dimension scores where 1 indicates no problems and 5 indicates extreme problems. EQ-5D-5L VAS records the respondent's self-rated, visual analogue scale score on a scale of 0-100, where 0 labelled as 'the worst health you can imagine and 100 labelled 'the best health you can imagine.' LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e., first 48 weeks).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=218 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=218 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score Change at Week 16	16.7 Units on a scale Standard Deviation 20.19	18.7 Units on a scale Standard Deviation 20.16
Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score Change at Week 48	16.5 Units on a scale Standard Deviation 22.77	16.1 Units on a scale Standard Deviation 21.71
Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score Change at Endpoint (Week 48 [LOCF])	16.5 Units on a scale Standard Deviation 22.77	16.1 Units on a scale Standard Deviation 21.71

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

The FACIT-F scale is a 13-item fatigue scale with a 7-day recall period. It measures the level of fatigue during the usual daily activities. The level of fatigue is measured on a 4-point Likert scale (0=very much fatigue to 4=not at all fatigue). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=220 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score Change at Week 16	9.1 Units on a scale Standard Deviation 10.57	11.6 Units on a scale Standard Deviation 10.12
Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score Change at Week 48	9.9 Units on a scale Standard Deviation 11.35	10.0 Units on a scale Standard Deviation 11.11
Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score Change at Endpoint (Week 48 [LOCF])	9.9 Units on a scale Standard Deviation 11.35	10.0 Units on a scale Standard Deviation 11.11

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

The HADS Score is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression. Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety. Cases of anxiety or depression are each defined by subscale scores of 8 or greater and categorized as normal (score of 0 to 7), mild (score of 8 to 10), moderate (score of 11 to 14), and severe (score of 15 to 21). LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=216 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=217 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Week 16: Anxiety	-2.5 Units on a scale Standard Deviation 3.43	-2.5 Units on a scale Standard Deviation 3.88
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Week 16: Depression	-2.5 Units on a scale Standard Deviation 3.59	-2.4 Units on a scale Standard Deviation 3.41
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Week 48: Anxiety	-2.5 Units on a scale Standard Deviation 3.64	-2.7 Units on a scale Standard Deviation 4.05
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Week 48: Depression	-2.4 Units on a scale Standard Deviation 4.00	-2.2 Units on a scale Standard Deviation 3.97
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Endpoint (Week 48 [LOCF]): Anxiety	-2.5 Units on a scale Standard Deviation 3.64	-2.7 Units on a scale Standard Deviation 4.05
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score Change at Endpoint (Week 48 [LOCF]): Depression	-2.4 Units on a scale Standard Deviation 4.00	-2.2 Units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

The WPAI questionnaire is a well-validated instrument to measure impairments in work and activities. It is a 6-item questionnaire with a 7-day recall period. The WPAI questionnaire produces 4 types of scores: absenteeism (work time missed), presenteesism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=212 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=215 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in WPAI Score Absenteeism: Change at Week 16	-12.9 Units on a scale Standard Deviation 31.39	-12.5 Units on a scale Standard Deviation 30.86
Change From Baseline in WPAI Score Absenteeism: Change at Week 48	-13.9 Units on a scale Standard Deviation 34.13	-14.8 Units on a scale Standard Deviation 30.22
Change From Baseline in WPAI Score Absenteeism: Change at Endpoint (Week 48 [LOCF])	-13.0 Units on a scale Standard Deviation 34.87	-12.1 Units on a scale Standard Deviation 31.92
Change From Baseline in WPAI Score Presenteeism: Change at Week 16	-23.3 Units on a scale Standard Deviation 27.76	-26.2 Units on a scale Standard Deviation 30.09
Change From Baseline in WPAI Score Presenteeism: Change at Week 48	-30.0 Units on a scale Standard Deviation 31.83	-26.0 Units on a scale Standard Deviation 28.90
Change From Baseline in WPAI Score Presenteeism: Change at Endpoint (Week 48 [LOCF])	-26.5 Units on a scale Standard Deviation 30.50	-22.5 Units on a scale Standard Deviation 30.99
Change From Baseline in WPAI Score Work Productivity Loss: Change at Week 16	-25.2 Units on a scale Standard Deviation 27.71	-27.2 Units on a scale Standard Deviation 31.79
Change From Baseline in WPAI Score Work Productivity Loss: Change at Week 48	-33.0 Units on a scale Standard Deviation 33.98	-28.0 Units on a scale Standard Deviation 31.66
Change From Baseline in WPAI Score Work Productivity Loss: Change at Endpoint (Week 48 [LOCF])	-29.1 Units on a scale Standard Deviation 32.91	-24.1 Units on a scale Standard Deviation 33.97
Change From Baseline in WPAI Score Activity Impairment: Change at Week 16	-24.1 Units on a scale Standard Deviation 27.23	-27.3 Units on a scale Standard Deviation 26.77
Change From Baseline in WPAI Score Activity Impairment: Change at Week 48	-29.2 Units on a scale Standard Deviation 29.65	-24.8 Units on a scale Standard Deviation 28.96
Change From Baseline in WPAI Score Activity Impairment: Change at Endpoint (Week 48 [LOCF])	-25.5 Units on a scale Standard Deviation 29.13	-23.6 Units on a scale Standard Deviation 29.08

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Time lost from work was collected by asking the participants a single question, "How many days did you miss from work due to your Crohn's disease in the last 4 weeks?" LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=133 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=139 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Time Lost From Work Change at Week 16	-1.7 Days Standard Deviation 4.32	-1.8 Days Standard Deviation 6.03
Change From Baseline in Time Lost From Work Change at Week 48	-1.8 Days Standard Deviation 4.58	-2.2 Days Standard Deviation 5.99
Change From Baseline in Time Lost From Work Change at Endpoint (Week 48 [LOCF])	-1.8 Days Standard Deviation 4.58	-2.2 Days Standard Deviation 5.99

SECONDARY outcome

Timeframe: Up to Week 48

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

An adverse event is any untoward medical event that occurs in participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48	188 Participants	179 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Change from baseline in body weight were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Body Weight Change at Week 16	1.56 Kilograms (Kg) Standard Deviation 2.996	1.16 Kilograms (Kg) Standard Deviation 3.586
Change From Baseline in Body Weight Change at Week 48	2.38 Kilograms (Kg) Standard Deviation 4.682	1.39 Kilograms (Kg) Standard Deviation 4.877
Change From Baseline in Body Weight Change at Endpoint (Week 48 [LOCF])	2.38 Kilograms (Kg) Standard Deviation 4.682	1.39 Kilograms (Kg) Standard Deviation 4.877

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Change from baseline in BMI were reported. BMI is a person's weight (in kilograms) divided by the square of height (in meters).LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Body Mass Index (BMI) Change at Week 16	0.54 Kilograms per meter square (Kg/m^2) Standard Deviation 1.052	0.37 Kilograms per meter square (Kg/m^2) Standard Deviation 1.236
Change From Baseline in Body Mass Index (BMI) Change at Week 48	0.82 Kilograms per meter square (Kg/m^2) Standard Deviation 1.622	0.46 Kilograms per meter square (Kg/m^2) Standard Deviation 1.665
Change From Baseline in Body Mass Index (BMI) Change at Endpoint (Week 48 [LOCF])	0.82 Kilograms per meter square (Kg/m^2) Standard Deviation 1.622	0.46 Kilograms per meter square (Kg/m^2) Standard Deviation 1.665

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Change from baseline in Blood Pressure (Systolic Blood Pressure \[SPB\] and Diastolic Blood Pressure \[DBP\]) were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Blood Pressure SBP: Change at Week 16	2.3 Millimeter of mercury (mmHg) Standard Deviation 13.16	0.3 Millimeter of mercury (mmHg) Standard Deviation 12.59
Change From Baseline in Blood Pressure SBP: Change at Week 48	1.9 Millimeter of mercury (mmHg) Standard Deviation 13.21	0.5 Millimeter of mercury (mmHg) Standard Deviation 12.47
Change From Baseline in Blood Pressure SBP: Change at Endpoint (Week 48 [LOCF])	1.9 Millimeter of mercury (mmHg) Standard Deviation 13.21	0.5 Millimeter of mercury (mmHg) Standard Deviation 12.47
Change From Baseline in Blood Pressure DBP: Change at Week 16	1.1 Millimeter of mercury (mmHg) Standard Deviation 9.46	0.8 Millimeter of mercury (mmHg) Standard Deviation 9.81
Change From Baseline in Blood Pressure DBP: Change at Week 48	1.2 Millimeter of mercury (mmHg) Standard Deviation 10.02	0.6 Millimeter of mercury (mmHg) Standard Deviation 9.85
Change From Baseline in Blood Pressure DBP: Change at Endpoint (Week 48 [LOCF])	1.2 Millimeter of mercury (mmHg) Standard Deviation 10.02	0.6 Millimeter of mercury (mmHg) Standard Deviation 9.85

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Population: FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.

Change from baseline in pulse rate were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Outcome measures

Outcome measures
Measure	Maintenance Period: Treat to Target n=219 Participants Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 Participants Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Change From Baseline in Pulse Rate Change at Week 16	-1.5 Beats/minute Standard Deviation 11.98	-2.0 Beats/minute Standard Deviation 11.51
Change From Baseline in Pulse Rate Change at Week 48	-0.2 Beats/minute Standard Deviation 13.39	-1.7 Beats/minute Standard Deviation 12.16
Change From Baseline in Pulse Rate Change at Endpoint (Week 48 [LOCF])	-0.2 Beats/minute Standard Deviation 13.39	-1.7 Beats/minute Standard Deviation 12.16

Adverse Events

Induction Period

Serious events: 28 serious events

Other events: 238 other events

Deaths: 0 deaths

Maintenance Period: Treat to Target

Serious events: 26 serious events

Other events: 158 other events

Deaths: 2 deaths

Maintenance Period: Routine Care

Serious events: 29 serious events

Other events: 150 other events

Deaths: 0 deaths

Extension Period: Treat to Target

Serious events: 21 serious events

Other events: 125 other events

Deaths: 0 deaths

Extension Period: Routine Care

Serious events: 23 serious events

Other events: 135 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Induction Period n=498 participants at risk Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.	Maintenance Period: Treat to Target n=219 participants at risk Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 participants at risk Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.	Extension Period: Treat to Target n=147 participants at risk From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.	Extension Period: Routine Care n=176 participants at risk From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 mg/L and fecal calprotectin \<=250 mcg/g) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.
Blood and lymphatic system disorders Anaemia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Cardiac disorders Angina Pectoris	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Cardiac disorders Cardiac Failure Acute	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Eye disorders Cataract	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Abdominal Pain	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Anal Fistula	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Colitis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Constipation	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Crohn's Disease	1.2% 6/498 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.6% 8/221 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Diarrhoea	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Dysphagia	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Fistula of Small Intestine	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Ileus	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Intestinal Stenosis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Intra-Abdominal Fluid Collection	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Large Intestine Perforation	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Large Intestine Polyp	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Subileus	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Vomiting	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Asthenia	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Cardiac Death	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Death	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Malaise	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Non-Cardiac Chest Pain	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Pyrexia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Abdominal Abscess	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Abdominal Wall Abscess	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Abscess Intestinal	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Anal Abscess	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Appendicitis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Bartholinitis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Campylobacter Infection	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Covid-19 Pneumonia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Enteritis Infectious	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Erysipelas	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Gastroenteritis	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Infectious Colitis	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Large Intestine Infection	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Perirectal Abscess	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Pharyngitis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Pneumonia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Injury, poisoning and procedural complications Head Injury	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Investigations Body Temperature Increased	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Back Pain	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Neoplasm	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma Metastatic	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial Spreading Melanoma Stage Unspecified	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Dizziness	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Dizziness Exertional	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Sciatica	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Temporal Lobe Epilepsy	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Psychiatric disorders Major Depression	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Psychiatric disorders Suicide Attempt	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Renal and urinary disorders Ureterolithiasis	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Reproductive system and breast disorders Female Genital Tract Fistula	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Vascular disorders Hypertension	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.

Other adverse events

Other adverse events
Measure	Induction Period n=498 participants at risk Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.	Maintenance Period: Treat to Target n=219 participants at risk Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study.	Maintenance Period: Routine Care n=221 participants at risk Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.	Extension Period: Treat to Target n=147 participants at risk From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.	Extension Period: Routine Care n=176 participants at risk From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 mg/L and fecal calprotectin \<=250 mcg/g) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.
Blood and lymphatic system disorders Anaemia	2.8% 14/498 • Number of events 14 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.7% 8/219 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.0% 11/221 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.4% 8/147 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.5% 8/176 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Ear and labyrinth disorders Vertigo	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Eye disorders Cataract	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Eye disorders Dry Eye	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Abdominal Distension	1.0% 5/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 6/221 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Abdominal Pain	3.6% 18/498 • Number of events 26 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	10.5% 23/219 • Number of events 31 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	7.7% 17/221 • Number of events 22 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	15.6% 23/147 • Number of events 36 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	12.5% 22/176 • Number of events 34 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Abdominal Pain Upper	1.2% 6/498 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/219 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.8% 7/147 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Anal Fissure	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 6/221 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Anal Fistula	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.7% 3/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Constipation	1.4% 7/498 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 6/221 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Crohn's Disease	1.8% 9/498 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	7.3% 16/219 • Number of events 17 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	9.5% 21/221 • Number of events 24 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	12.2% 18/147 • Number of events 19 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	11.4% 20/176 • Number of events 22 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Diarrhoea	1.8% 9/498 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.0% 11/219 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.9% 13/221 • Number of events 15 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	11.6% 17/147 • Number of events 21 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	9.7% 17/176 • Number of events 24 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Dyspepsia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Flatulence	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Frequent Bowel Movements	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Haematochezia	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Haemorrhoids	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Nausea	2.4% 12/498 • Number of events 16 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.5% 12/219 • Number of events 18 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.4% 12/221 • Number of events 15 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	7.5% 11/147 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	9.1% 16/176 • Number of events 21 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Toothache	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Gastrointestinal disorders Vomiting	1.4% 7/498 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 9/219 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 9/221 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	6.2% 11/176 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Asthenia	2.0% 10/498 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.7% 8/219 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 6/221 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	6.8% 10/147 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.5% 8/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Fatigue	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/221 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Influenza Like Illness	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
General disorders Pyrexia	5.0% 25/498 • Number of events 33 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	11.4% 25/219 • Number of events 37 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	8.6% 19/221 • Number of events 21 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	10.2% 15/147 • Number of events 25 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	14.8% 26/176 • Number of events 35 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Anal Abscess	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Bronchitis	1.0% 5/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.6% 8/221 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	6.2% 11/176 • Number of events 15 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Covid-19	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.7% 3/176 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Gastroenteritis	1.0% 5/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/219 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	8.2% 12/147 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.1% 9/176 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Gastroenteritis Viral	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Gastrointestinal Infection	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Influenza	2.6% 13/498 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.5% 12/219 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.0% 11/221 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	9.5% 14/147 • Number of events 15 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	8.0% 14/176 • Number of events 16 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Nasopharyngitis	8.8% 44/498 • Number of events 48 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	13.2% 29/219 • Number of events 48 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	13.1% 29/221 • Number of events 39 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	15.6% 23/147 • Number of events 46 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	19.9% 35/176 • Number of events 58 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Oral Herpes	1.2% 6/498 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Pharyngitis	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 9/219 • Number of events 11 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/221 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.8% 7/147 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.7% 10/176 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Rhinitis	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Sinusitis	1.0% 5/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Tonsillitis	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Tooth Abscess	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Upper Respiratory Tract Infection	1.2% 6/498 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.5% 8/176 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Urinary Tract Infection	1.0% 5/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Infections and infestations Vaginal Infection	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Injury, poisoning and procedural complications Contusion	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Injury, poisoning and procedural complications Ligament Sprain	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Investigations Alanine Aminotransferase Increased	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Investigations C-Reactive Protein Increased	1.2% 6/498 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Investigations Serum Ferritin Decreased	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Decreased Appetite	0.80% 4/498 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Folate Deficiency	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Hypokalaemia	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Hypophosphataemia	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Iron Deficiency	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Vitamin B12 Deficiency	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Metabolism and nutrition disorders Vitamin D Deficiency	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 6/221 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.0% 7/176 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 29/498 • Number of events 31 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	11.0% 24/219 • Number of events 30 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	8.6% 19/221 • Number of events 22 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	16.3% 24/147 • Number of events 29 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	14.8% 26/176 • Number of events 35 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Arthritis	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Back Pain	2.2% 11/498 • Number of events 11 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/219 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.4% 12/221 • Number of events 12 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	10.2% 15/147 • Number of events 17 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	10.2% 18/176 • Number of events 25 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Myalgia	1.2% 6/498 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 7 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Neck Pain	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.0% 7/176 • Number of events 13 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/221 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Headache	7.2% 36/498 • Number of events 47 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	11.0% 24/219 • Number of events 42 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	9.5% 21/221 • Number of events 51 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	13.6% 20/147 • Number of events 62 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	15.9% 28/176 • Number of events 92 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Nervous system disorders Migraine	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/147 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Psychiatric disorders Anxiety	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 6/176 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Psychiatric disorders Depression	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/219 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Psychiatric disorders Insomnia	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Renal and urinary disorders Renal Colic	0.00% 0/498 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.91% 2/219 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Reproductive system and breast disorders Dysmenorrhoea	0.80% 4/498 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/219 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.57% 1/176 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 6/498 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.7% 8/219 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/221 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.1% 6/147 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	6.8% 12/176 • Number of events 15 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.40% 2/498 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/221 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.4% 8/147 • Number of events 11 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	5.1% 9/176 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.68% 1/147 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Alopecia	1.2% 6/498 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Eczema	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Erythema	0.80% 4/498 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 3/221 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.7% 4/147 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 4/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Pruritus	0.80% 4/498 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/219 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.90% 2/221 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.4% 5/147 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.1% 2/176 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Rash	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.3% 5/219 • Number of events 6 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	3.2% 7/221 • Number of events 8 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	6.1% 9/147 • Number of events 10 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	4.0% 7/176 • Number of events 9 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Skin and subcutaneous tissue disorders Skin Lesion	0.20% 1/498 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.45% 1/221 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.0% 3/147 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.00% 0/176 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Vascular disorders Hypertension	0.60% 3/498 • Number of events 3 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	0.46% 1/219 • Number of events 1 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.8% 4/221 • Number of events 4 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	1.4% 2/147 • Number of events 2 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.	2.8% 5/176 • Number of events 5 • Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap. For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.

Additional Information

European Medicines Agency (EMEA) Advisor-Immunology

Janssen-Cilag International N.V.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER