Trial Outcomes & Findings for Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis (NCT NCT02039505)

NCT ID: NCT02039505

Last Updated: 2019-04-25

Results Overview

Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores (rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment), a global assessment by the physician, and an endoscopic subscore. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 292 participants
• Primary outcome timeframe: Week 10
• Results posted on: 2019-04-25

Participant Flow

Participants took part in the study at 86 investigative sites in Japan from 04 February 2014 to 28 June 2018.

Participants with moderate to severe ulcerative colitis (UC) were enrolled. 292 participants enrolled in induction phase, 109 participants entered maintenance phase and 259 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and Week 154 through study with maximum 94 weeks.

Participant milestones

Measure	Induction Phase: Cohort 1, Placebo Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Induction Phase (Week 0 to Week 14) STARTED	82	164	46	0	0	0	0
Induction Phase (Week 0 to Week 14) COMPLETED	78	155	36	0	0	0	0
Induction Phase (Week 0 to Week 14) NOT COMPLETED	4	9	10	0	0	0	0
Maintenance Phase (Week 14 to Week 60) STARTED	0	0	0	42	41	26	0
Maintenance Phase (Week 14 to Week 60) COMPLETED	0	0	0	18	30	12	0
Maintenance Phase (Week 14 to Week 60) NOT COMPLETED	0	0	0	24	11	14	0
Open-Label (Week 10 up to Week 154) STARTED	0	0	0	0	0	0	259
Open-Label (Week 10 up to Week 154) COMPLETED	0	0	0	0	0	0	188
Open-Label (Week 10 up to Week 154) NOT COMPLETED	0	0	0	0	0	0	71

Reasons for withdrawal

Measure	Induction Phase: Cohort 1, Placebo Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Induction Phase (Week 0 to Week 14) Pretreatment Event/Adverse Event	2	8	7	0	0	0	0
Induction Phase (Week 0 to Week 14) Lack of Efficacy	1	1	3	0	0	0	0
Induction Phase (Week 0 to Week 14) Major Protocol Deviation	1	0	0	0	0	0	0
Maintenance Phase (Week 14 to Week 60) Lack of Efficacy	0	0	0	13	8	12	0
Maintenance Phase (Week 14 to Week 60) Pretreatment Event/Adverse Event	0	0	0	6	1	1	0
Maintenance Phase (Week 14 to Week 60) Voluntary Withdrawal	0	0	0	3	2	1	0
Maintenance Phase (Week 14 to Week 60) Pregnancy	0	0	0	2	0	0	0
Open-Label (Week 10 up to Week 154) Lack of Efficacy	0	0	0	0	0	0	44
Open-Label (Week 10 up to Week 154) Pretreatment Event/Adverse Event	0	0	0	0	0	0	19
Open-Label (Week 10 up to Week 154) Voluntary Withdrawal	0	0	0	0	0	0	7
Open-Label (Week 10 up to Week 154) Major Protocol Deviation	0	0	0	0	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Total n=292 Participants Total of all reporting groups
Age, Continuous	44.0 years STANDARD_DEVIATION 15.97 • n=82 Participants	42.3 years STANDARD_DEVIATION 14.42 • n=164 Participants	42.4 years STANDARD_DEVIATION 15.60 • n=46 Participants	42.8 years STANDARD_DEVIATION 15.02 • n=292 Participants
Sex: Female, Male Female	27 Participants n=82 Participants	65 Participants n=164 Participants	20 Participants n=46 Participants	112 Participants n=292 Participants
Sex: Female, Male Male	55 Participants n=82 Participants	99 Participants n=164 Participants	26 Participants n=46 Participants	180 Participants n=292 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	82 Participants n=82 Participants	164 Participants n=164 Participants	46 Participants n=46 Participants	292 Participants n=292 Participants
Weight	60.36 kg STANDARD_DEVIATION 12.411 • n=82 Participants	58.58 kg STANDARD_DEVIATION 11.640 • n=164 Participants	57.74 kg STANDARD_DEVIATION 10.559 • n=46 Participants	58.95 kg STANDARD_DEVIATION 11.699 • n=292 Participants
Body Mass Index (BMI)	21.76 kg/m^2 STANDARD_DEVIATION 3.660 • n=82 Participants	21.72 kg/m^2 STANDARD_DEVIATION 3.411 • n=164 Participants	21.12 kg/m^2 STANDARD_DEVIATION 2.714 • n=46 Participants	21.64 kg/m^2 STANDARD_DEVIATION 3.382 • n=292 Participants
Smoking Classification Never smoked	44 Participants n=82 Participants	85 Participants n=164 Participants	23 Participants n=46 Participants	152 Participants n=292 Participants
Smoking Classification Current smoker	3 Participants n=82 Participants	9 Participants n=164 Participants	5 Participants n=46 Participants	17 Participants n=292 Participants
Smoking Classification Ex-smoker	35 Participants n=82 Participants	70 Participants n=164 Participants	18 Participants n=46 Participants	123 Participants n=292 Participants
Duration of Ulcerative Colitis (UC)	8.57 years STANDARD_DEVIATION 7.973 • n=82 Participants	7.23 years STANDARD_DEVIATION 6.230 • n=164 Participants	9.19 years STANDARD_DEVIATION 7.725 • n=46 Participants	7.91 years STANDARD_DEVIATION 7.022 • n=292 Participants
Complete Mayo Score	8.1 score on a scale STANDARD_DEVIATION 1.50 • n=82 Participants	8.3 score on a scale STANDARD_DEVIATION 1.54 • n=164 Participants	8.3 score on a scale STANDARD_DEVIATION 1.66 • n=46 Participants	8.3 score on a scale STANDARD_DEVIATION 1.54 • n=292 Participants
Disease Localization Total Colitis	51 Participants n=82 Participants	101 Participants n=164 Participants	32 Participants n=46 Participants	184 Participants n=292 Participants
Disease Localization Left-sided Colitis	31 Participants n=82 Participants	63 Participants n=164 Participants	14 Participants n=46 Participants	108 Participants n=292 Participants
Extraintestinal Manifestations Had No Extraintestinal Manifestations	66 Participants n=82 Participants	111 Participants n=164 Participants	32 Participants n=46 Participants	209 Participants n=292 Participants
Extraintestinal Manifestations Had Extraintestinal Manifestations	16 Participants n=82 Participants	53 Participants n=164 Participants	14 Participants n=46 Participants	83 Participants n=292 Participants

PRIMARY outcome

Timeframe: Week 10

Population: Full analysis set (FAS) included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.

Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores (rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment), a global assessment by the physician, and an endoscopic subscore. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With a Clinical Response at Week 10 in Induction Phase	32.9 percentage of participants Interval 22.942 to 44.186	39.6 percentage of participants Interval 32.093 to 47.557	—	—	—	—	—

PRIMARY outcome

Timeframe: Week 60

Population: FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Clinical Remission at Week 60 in Maintenance Phase	31.0 percentage of participants Interval 17.622 to 47.086	56.1 percentage of participants Interval 39.75 to 71.531	—	—	—	—	—

PRIMARY outcome

Timeframe: From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)	43 Participants	82 Participants	33 Participants	33 Participants	36 Participants	18 Participants	241 Participants

PRIMARY outcome

Timeframe: From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With TEAE Related to Body Weight	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With TEAE Related to Vital Signs	2 Participants	5 Participants	3 Participants	2 Participants	2 Participants	0 Participants	24 Participants

PRIMARY outcome

Timeframe: From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With TEAE Related to Electrocardiogram (ECG)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.

The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /µL, WBC <2000 /µL, Platelets <7.5 10^4/µL, Neutrophils <1000 /µL, alanine aminotransferase (ALT) >3.0 U/L x upper limit of normal (ULN), aspartate aminotransferase (AST) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN were considered markedly abnormal. Only laboratory parameters with events were represented.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 Participants Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With Markedly Abnormal Laboratory Parameters Values Hemoglobin (g/dL) <=7	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants	6 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Lymphocytes (/µL) <500	6 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	20 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values White Blood Cell (WBC) (/µL) <2000	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Neutrophils (/µL) <1000	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Alanine Aminotransferase (ALT) (U/L) >3.0 x ULN	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Aspartate Aminotransferase (AST) (U/L) >3.0 x ULN	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Total Bilirubin (mg/dL) >2.0 x ULN	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Laboratory Parameters Values Amylase (U/L) >2.0 x ULN	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 10

Population: FAS included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.

Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Clinical Remission at Week 10 in Induction Phase	12.2 percentage of participants Interval 6.006 to 21.286	18.3 percentage of participants Interval 12.695 to 25.072	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 10

Population: FAS included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.

Mucosal healing is defined as a Mayo endoscopic subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=82 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Mucosal Healing at Week 10 in Induction Phase	30.5 percentage of participants Interval 20.796 to 41.638	36.6 percentage of participants Interval 29.213 to 44.452	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 10 and 60

Population: FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

Durable clinical response is defined as reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Weeks 10 and 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Durable Clinical Response in Maintenance Phase	35.7 percentage of participants Interval 21.551 to 51.974	65.9 percentage of participants Interval 49.405 to 79.917	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 60

Population: FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

Mucosal healing is defined as a Mayo endoscopic subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Mucosal Healing at Week 60 in Maintenance Phase	33.3 percentage of participants Interval 19.567 to 49.549	63.4 percentage of participants Interval 46.936 to 77.877	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 10 and 60

Population: FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.

Durable clinical remission is defined as complete Mayo score of ≤2 points and no individual subscore >1 point at both Weeks 10 and 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Durable Remission in Maintenance Phase	16.7 percentage of participants Interval 6.974 to 31.364	26.8 percentage of participants Interval 14.221 to 42.944	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 60

Population: Participants from FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analyzed at the given timepoint.

Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=15 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=13 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Percentage of Participants With Corticosteroid-Free Remission at Week 60 in Maintenance Phase	20.0 percentage of participants Interval 4.331 to 48.089	46.2 percentage of participants Interval 19.223 to 74.865	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 2, 6, 10 and 14

Population: Participants from FAS, who received at least one dose of study drug in induction phase for whom sample was available for pharmacokinetic (PK) analysis. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=164 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Serum Vedolizumab Concentration in Induction Phase Week 2	31.93 μg/mL Standard Deviation 9.0617	33.96 μg/mL Standard Deviation 7.7002	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 6	29.58 μg/mL Standard Deviation 12.965	31.53 μg/mL Standard Deviation 12.937	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 10	31.42 μg/mL Standard Deviation 14.462	36.63 μg/mL Standard Deviation 16.058	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 14	16.09 μg/mL Standard Deviation 7.3624	19.04 μg/mL Standard Deviation 6.6528	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 2, 6, 10, 14, 22, 30 and 60

Population: Participants from FAS, who were randomized and received at least one dose of the study drug in the maintenance phase for whom sample was available for PK analysis. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Serum Vedolizumab Concentration in Maintenance Phase Week 2	32.87 μg/mL Standard Deviation 9.8729	34.92 μg/mL Standard Deviation 7.3732	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 6	32.80 μg/mL Standard Deviation 12.953	35.87 μg/mL Standard Deviation 11.983	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 10	39.21 μg/mL Standard Deviation 15.076	41.02 μg/mL Standard Deviation 11.955	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 14	16.05 μg/mL Standard Deviation 7.4224	17.31 μg/mL Standard Deviation 7.1914	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 22	2.913 μg/mL Standard Deviation 2.3243	14.45 μg/mL Standard Deviation 6.0327	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 30	0.2200 μg/mL Standard Deviation 0.48146	13.77 μg/mL Standard Deviation 6.3692	—	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 60	0.000 μg/mL Standard Deviation 0.0000	21.16 μg/mL Standard Deviation 8.9078	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Participants who underwent proper AVA test out of "the FAS in the induction phase" and, "the participants who received at least one dose of study drug in the Cohort 2" were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.

Blood samples were collected and tested for serum concentration of anti-vedolizumab antibodies in a laboratory by means of electrochemoluminescent (ECL) assay.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=164 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 0	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 10	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase 16 Weeks After Last Administration	1 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Participants who underwent proper AVA test out of the FAS, the participants who received at least one dose of study drug in the maintenance phase were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.

Blood samples were collected and tested for serum concentration of anti-vedolizumab antibodies in a laboratory by means of ECL assay.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 0	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 10	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 30	4 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 60	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase 16 Weeks After Last Administration	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Participants who underwent proper AVA test out of "the FAS in the induction phase" and "the participants who received at least one dose of study drug in the Cohort 2" were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.

Blood samples were collected, and serum neutralizing AVA was determined only for the AVA-positive samples in a laboratory by means of ECL assay.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=164 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=46 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 0	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 10	1 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase 16 Weeks After Last Administration	1 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)

Population: Participants who underwent proper AVA test out of the FAS, the participants who received at least one dose of study drug in the maintenance phase were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.

Blood samples were collected, and serum neutralizing AVA was determined only for the AVA-positive samples in a laboratory by means of ECL assay.

Outcome measures

Measure	Induction Phase: Cohort 1, Placebo n=42 Participants Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=41 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 0	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 10	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 30	3 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 60	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase 16 Weeks After Last Administration	0 Participants	0 Participants	—	—	—	—	—

Adverse Events

Induction Phase: Cohort 1, Placebo

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Induction Phase: Cohort 1, Vedolizumab 300 mg

Serious events: 10 serious events

Other events: 28 other events

Deaths: 0 deaths

Induction Phase: Cohort 2, Vedolizumab 300 mg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Maintenance Phase: Placebo

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Maintenance Phase: Vedolizumab 300 mg

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

Maintenance Phase: Placebo Continuation

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Open-Label Cohort: Vedolizumab 300 mg

Serious events: 48 serious events

Other events: 191 other events

Deaths: 0 deaths

Serious adverse events

Measure	Induction Phase: Cohort 1, Placebo n=82 participants at risk Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 participants at risk Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 participants at risk Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	2.4% 2/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 6/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 4/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 2/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.9% 2/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.7% 25/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Anal abscess	1.2% 1/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Clostridium difficile infection	1.2% 1/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 2/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute prerenal failure	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 1/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.61% 1/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Enterocolitis bacterial	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Appendicitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.77% 2/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Endometriosis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Granulomatous dermatitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Chest X-ray abnormal	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Eosinophil count increased	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Facial paralysis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Neuritis cranial	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Angina pectoris	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.77% 2/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Cataract	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.77% 2/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anal stenosis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Duodenitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastritis erosive	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Internal hernia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Drug intolerance	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Drug hypersensitivity	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.77% 2/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Clostridium difficile colitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Enteritis infectious	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Enterocolitis viral	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Foreign body	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.39% 1/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Induction Phase: Cohort 1, Placebo n=82 participants at risk Vedolizumab placebo-matching, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Cohort 1, Vedolizumab 300 mg n=164 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, and 6 in the induction phase.	Induction Phase: Cohort 2, Vedolizumab 300 mg n=46 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Placebo n=42 participants at risk Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Vedolizumab 300 mg n=41 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo Continuation n=26 participants at risk Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved clinical response at Week 10 received placebo in maintenance phase without randomization.	Open-Label Cohort: Vedolizumab 300 mg n=259 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Infections and infestations Viral upper respiratory tract infection	9.8% 8/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.0% 23/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	26.1% 12/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 9/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	43.9% 18/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.8% 8/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.2% 130/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	2.4% 2/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 6/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.9% 2/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.9% 23/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 2/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Gastroenteritis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 3/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 13/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 2/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.9% 2/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.5% 4/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 18/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.3% 3/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.3% 3/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.4% 14/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.3% 3/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dental caries	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.8% 4/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 3/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 13/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.3% 19/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.3% 3/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.4% 14/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.3% 24/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 22/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 17/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.2% 16/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/82 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/164 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/46 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/41 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.4% 14/259 • From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER