Trial Outcomes & Findings for Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease (NCT NCT02038920)

NCT ID: NCT02038920

Last Updated: 2019-12-09

Results Overview

A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 157 participants
• Primary outcome timeframe: Week 10
• Results posted on: 2019-12-09

Participant Flow

Participants took part in the study at 77 investigative sites in Japan from 28 Jan 2014 to 21 May 2019.

Participants with moderate to severe Crohn's disease were enrolled. 157 participants enrolled in induction phase, 41 participants entered maintenance phase and 134 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and 154 through study with maximum of 94 weeks of treatment.

Participant milestones

Measure	Induction Phase: Vedolizumab, 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Induction Phase (Week 0 to 14) STARTED	79	78	0	0	0	0
Induction Phase (Week 0 to 14) COMPLETED	73	66	0	0	0	0
Induction Phase (Week 0 to 14) NOT COMPLETED	6	12	0	0	0	0
Maintenance Phase (Week 14 to 60) STARTED	0	0	12	12	17	0
Maintenance Phase (Week 14 to 60) COMPLETED	0	0	7	4	5	0
Maintenance Phase (Week 14 to 60) NOT COMPLETED	0	0	5	8	12	0
Open Label Cohort (Week 10 to 154) STARTED	0	0	0	0	0	134
Open Label Cohort (Week 10 to 154) COMPLETED	0	0	0	0	0	57
Open Label Cohort (Week 10 to 154) NOT COMPLETED	0	0	0	0	0	77

Reasons for withdrawal

Measure	Induction Phase: Vedolizumab, 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Induction Phase (Week 0 to 14) Pretreatment Event/Adverse Event	3	11	0	0	0	0
Induction Phase (Week 0 to 14) Voluntary Withdrawal	2	0	0	0	0	0
Induction Phase (Week 0 to 14) Lack of Efficacy	1	1	0	0	0	0
Maintenance Phase (Week 14 to 60) Pretreatment Event/Adverse Event	0	0	2	4	2	0
Maintenance Phase (Week 14 to 60) Lost to Follow-up	0	0	1	0	0	0
Maintenance Phase (Week 14 to 60) Lack of Efficacy	0	0	2	4	10	0
Open Label Cohort (Week 10 to 154) Pretreatment Event/Adverse Event	0	0	0	0	0	43
Open Label Cohort (Week 10 to 154) Lost to Follow-up	0	0	0	0	0	1
Open Label Cohort (Week 10 to 154) Voluntary Withdrawal	0	0	0	0	0	7
Open Label Cohort (Week 10 to 154) Pregnancy	0	0	0	0	0	1
Open Label Cohort (Week 10 to 154) Lack of Efficacy	0	0	0	0	0	23
Open Label Cohort (Week 10 to 154) Reason Not Specified	0	0	0	0	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Total n=157 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 12.25 • n=79 Participants	32.6 years STANDARD_DEVIATION 10.93 • n=78 Participants	33.3 years STANDARD_DEVIATION 11.60 • n=157 Participants
Sex: Female, Male Female	28 Participants n=79 Participants	26 Participants n=78 Participants	54 Participants n=157 Participants
Sex: Female, Male Male	51 Participants n=79 Participants	52 Participants n=78 Participants	103 Participants n=157 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	79 Participants n=79 Participants	78 Participants n=78 Participants	157 Participants n=157 Participants
Height	166.3 cm STANDARD_DEVIATION 8.73 • n=79 Participants	166.4 cm STANDARD_DEVIATION 7.97 • n=78 Participants	166.4 cm STANDARD_DEVIATION 8.33 • n=157 Participants
Weight	58.53 kg STANDARD_DEVIATION 14.095 • n=79 Participants	55.03 kg STANDARD_DEVIATION 8.928 • n=78 Participants	56.79 kg STANDARD_DEVIATION 11.906 • n=157 Participants
Body Mass Index (BMI)	21.15 kg/m^2 STANDARD_DEVIATION 4.942 • n=79 Participants	19.81 kg/m^2 STANDARD_DEVIATION 2.567 • n=78 Participants	20.48 kg/m^2 STANDARD_DEVIATION 3.989 • n=157 Participants
Duration of Crohn's Disease	7.20 years n=79 Participants	8.35 years n=78 Participants	7.90 years n=157 Participants
C-Reactive Protein (CRP)	2.234 mg/dL STANDARD_DEVIATION 2.1763 • n=79 Participants	2.848 mg/dL STANDARD_DEVIATION 3.2303 • n=78 Participants	2.539 mg/dL STANDARD_DEVIATION 2.7593 • n=157 Participants
CDAI Score at Week 0	303.9 score on a scale STANDARD_DEVIATION 63.19 • n=79 Participants	295.0 score on a scale STANDARD_DEVIATION 64.81 • n=78 Participants	299.5 score on a scale STANDARD_DEVIATION 63.95 • n=157 Participants
Disease Localization Small Intestine Type	13 Participants n=79 Participants	9 Participants n=78 Participants	22 Participants n=157 Participants
Disease Localization Large Intestine Type	11 Participants n=79 Participants	19 Participants n=78 Participants	30 Participants n=157 Participants
Disease Localization Small/large Intestine Type	55 Participants n=79 Participants	50 Participants n=78 Participants	105 Participants n=157 Participants
Smoking Classification Never Smoked	46 Participants n=79 Participants	42 Participants n=78 Participants	88 Participants n=157 Participants
Smoking Classification Current Smoker	13 Participants n=79 Participants	11 Participants n=78 Participants	24 Participants n=157 Participants
Smoking Classification Ex-smoker	20 Participants n=79 Participants	25 Participants n=78 Participants	45 Participants n=157 Participants
Extraintestinal Manifestations (Based on CDAI subscore) Had No Extraintestinal Manifestations	24 Participants n=79 Participants	22 Participants n=78 Participants	46 Participants n=157 Participants
Extraintestinal Manifestations (Based on CDAI subscore) Had Extraintestinal Manifestations	55 Participants n=79 Participants	56 Participants n=78 Participants	111 Participants n=157 Participants
Extraintestinal Manifestations (Based on Case Report Form) Had No Extraintestinal Manifestations	42 Participants n=79 Participants	52 Participants n=78 Participants	94 Participants n=157 Participants
Extraintestinal Manifestations (Based on Case Report Form) Had Extraintestinal Manifestations	37 Participants n=79 Participants	26 Participants n=78 Participants	63 Participants n=157 Participants
History of Prior Surgery for Crohn's Disease (CD) Had No Surgical History	55 Participants n=79 Participants	48 Participants n=78 Participants	103 Participants n=157 Participants
History of Prior Surgery for Crohn's Disease (CD) Had Surgical History	24 Participants n=79 Participants	30 Participants n=78 Participants	54 Participants n=157 Participants
Current Medical Condition Related to Fistula Had No Current Medical Condition	72 Participants n=79 Participants	66 Participants n=78 Participants	138 Participants n=157 Participants
Current Medical Condition Related to Fistula Had Current Medical Condition	7 Participants n=79 Participants	12 Participants n=78 Participants	19 Participants n=157 Participants

PRIMARY outcome

Timeframe: Week 10

Population: Full analysis set (FAS) in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.

A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response	26.6 percentage of participants Interval 17.268 to 37.72	16.7 percentage of participants Interval 9.184 to 26.813	—	—	—	—

PRIMARY outcome

Timeframe: Week 60

Population: FAS in the maintenance phase 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 the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Maintenance Phase: Percentage of Participants With Clinical Remission	41.7 percentage of participants Interval 15.165 to 72.333	16.7 percentage of participants Interval 2.086 to 48.414	—	—	—	—

PRIMARY outcome

Timeframe: From Baseline up 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 study participant who received a drug (including a study 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 TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)	49 Participants	42 Participants	9 Participants	10 Participants	12 Participants	130 Participants

PRIMARY outcome

Timeframe: From Baseline up 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.

Reported events on this outcome measure were "Weight Decreased".

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Number of Participants With TEAE Related to Body Weight (Weight Decreased)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From Baseline up 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). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Number of Participants With TEAE Related to Vital Signs Pyrexia	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants	19 Participants
Number of Participants With TEAE Related to Vital Signs Body Temperature Increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAE Related to Vital Signs Hypertension	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With TEAE Related to Vital Signs Orthostatic Hypotension	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Baseline up 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.

Reported events on this outcome measure were "Bundle Branch Block Right".

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Baseline up 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 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=11 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Hemoglobin (g/dL) <=7	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Lymphocytes (/uL) <500	7 Participants	6 Participants	1 Participants	2 Participants	1 Participants	18 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values WBC (/uL) <2000	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Platelets (10^4/uL) <7.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Neutrophils (/uL) <1000	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values ALT (GPT) (U/L) >3.0 x ULN	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values AST (GOT) (U/L) >3.0 x ULN	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Total Bilirubin (mg/dL) >2.0 x ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values Amylase (U/L) >2.0 x ULN	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 10

Population: FAS in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.

Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Induction Phase: Percentage of Participants With Clinical Remission	17.7 percentage of participants Interval 10.041 to 27.942	10.3 percentage of participants Interval 4.533 to 19.213	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 10

Population: Participants from 'FAS in the induction phase' with CRP value exceeding 0.30 mg/dL at Baseline were analyzed at given time point. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values Change from Baseline at Week 2	0.022 mg/dL Standard Deviation 2.1421	-0.125 mg/dL Standard Deviation 2.8417	—	—	—	—
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values Change from Baseline at Week 6	-0.089 mg/dL Standard Deviation 2.0266	0.130 mg/dL Standard Deviation 2.1674	—	—	—	—
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values Change from Baseline at Week 10	-0.164 mg/dL Standard Deviation 2.2729	0.077 mg/dL Standard Deviation 2.8690	—	—	—	—

SECONDARY outcome

Timeframe: Week 60

Population: FAS in the maintenance phase 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.

A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response	58.3 percentage of participants Interval 27.667 to 84.835	8.3 percentage of participants Interval 0.211 to 38.48	—	—	—	—

SECONDARY outcome

Timeframe: From Week 14 and Week 60

Population: FAS in the maintenance phase 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 participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Maintenance Phase: Percentage of Participants With Durable Clinical Remission	33.3 percentage of participants Interval 9.925 to 65.112	25.0 percentage of participants Interval 5.486 to 57.186	—	—	—	—

SECONDARY outcome

Timeframe: Week 60

Population: Participants from FAS in maintenance phase 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.

Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=5 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=3 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission	40.0 percentage of participants Interval 5.274 to 85.337	0.0 percentage of participants Interval 0.0 to 70.76	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 2, 6, 10 and 14

Population: Participants from 'FAS in Induction Phase', who were randomized and received at least one dose of the study drug in the induction phase and for whom samples were 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: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Serum Vedolizumab Concentration in Induction Phase Week 2	28.23 ug/mL Standard Deviation 11.018	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 6	21.01 ug/mL Standard Deviation 14.076	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 10	22.31 ug/mL Standard Deviation 14.049	—	—	—	—	—
Serum Vedolizumab Concentration in Induction Phase Week 14	12.24 ug/mL Standard Deviation 10.350	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 2, 6, 10, 14, 22, 30 and 60

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

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Serum Vedolizumab Concentration in Maintenance Phase Week 2	29.32 ug/mL Standard Deviation 13.880	30.54 ug/mL Standard Deviation 9.7495	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 6	25.19 ug/mL Standard Deviation 17.054	24.90 ug/mL Standard Deviation 14.490	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 10	26.24 ug/mL Standard Deviation 15.464	26.60 ug/mL Standard Deviation 15.642	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 14	11.20 ug/mL Standard Deviation 8.5793	13.72 ug/mL Standard Deviation 13.072	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 22	9.102 ug/mL Standard Deviation 6.1809	1.502 ug/mL Standard Deviation 2.8285	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 30	9.013 ug/mL Standard Deviation 6.8774	0.000 ug/mL Standard Deviation 0.0000	—	—	—	—
Serum Vedolizumab Concentration in Maintenance Phase Week 60	13.68 ug/mL Standard Deviation 4.2659	0.000 ug/mL Standard Deviation 0.0000	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

Population: Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 0	1 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 10	1 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase 16 Weeks After Last Administration	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

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

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
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	0 Participants	2 Participants	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 60	0 Participants	1 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, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

Population: Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 0	2 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 10	2 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 30	2 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 62	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 94	0 Participants	—	—	—	—	—
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort 16 Weeks After Last Administration	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase

Population: Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=79 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 0	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase Week 10	1 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase 16 Weeks After Last Administration	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase

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

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=12 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=12 Participants Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
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	0 Participants	2 Participants	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase Week 60	0 Participants	1 Participants	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase 16 Weeks After Last Administration	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort

Population: Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Measure	Induction Phase: Vedolizumab, 300 mg n=134 Participants Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance 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 CDAI-70 response at Week 10 and were randomized to receive placebo 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: 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 as a maximum duration in open-label phase.
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 62	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 0	2 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 10	2 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 30	1 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort Week 94	0 Participants	—	—	—	—	—
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort 16 Weeks After Last Administration	2 Participants	—	—	—	—	—

Adverse Events

Induction Phase: Vedolizumab, 300 mg

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Induction Phase: Placebo

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Maintenance Phase: Vedolizumab 300 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Maintenance Phase: Placebo

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Maintenance Phase: Placebo Continuation

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Open-Label: Vedolizumab 300 mg

Serious events: 70 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	Induction Phase: Vedolizumab, 300 mg n=79 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 participants at risk Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 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 as a maximum duration in open-label phase.
Gastrointestinal disorders Crohn's disease	2.5% 2/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.8% 10/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 35/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 fistula	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.5% 2/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ascites	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal obstruction	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.0% 4/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Subileus	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hepatic function abnormal	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Anaphylactoid reaction	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.0% 4/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 viral	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Thyroid adenoma	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 adhesions	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Cellulitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ileus	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 3/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal stenosis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 3/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Enterovesical fistula	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrointestinal haemorrhage	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ileal stenosis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal perforation	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Large intestinal stenosis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Large intestine perforation	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Melaena	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 obstruction	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Inflammation	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Drug-induced liver injury	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Abdominal abscess	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.5% 2/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.5% 2/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Device related infection	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Escherichia sepsis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Mesenteric abscess	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Mycotic endophthalmitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Otitis media	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Perirectal abscess	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Periumbilical abscess	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 bacterial	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Rectal abscess	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Sepsis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Septic shock	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intestinal anastomosis complication	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Post lumbar puncture syndrome	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypocalcaemia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypokalaemia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypomagnesaemia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Malnutrition	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dizziness	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dyslalia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Intracranial hypotension	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ureterolithiasis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pleurisy	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Mediastinitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.75% 1/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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: Vedolizumab, 300 mg n=79 participants at risk Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.	Induction Phase: Placebo n=78 participants at risk Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.	Maintenance Phase: Vedolizumab 300 mg n=12 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 CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.	Maintenance Phase: Placebo n=12 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 CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.	Maintenance Phase: Placebo Continuation n=17 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 CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.	Open-Label: Vedolizumab 300 mg n=134 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 as a maximum duration in open-label phase.
Gastrointestinal disorders Crohn's disease	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 5/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.8% 2/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.1% 27/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Nasopharyngitis	13.9% 11/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.1% 11/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	23.5% 4/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.0% 55/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	5.1% 4/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	1.3% 1/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.7% 9/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypoaesthesia	5.1% 4/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Iron deficiency anaemia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Diarrhoea	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.7% 9/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Constipation	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.2% 15/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Gastrooesophageal reflux disease	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.2% 11/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.2% 19/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Chest pain	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Swelling	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Allergy to metals	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Seasonal allergy	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.5% 10/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Conjunctivitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.8% 2/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dermatophytosis of nail	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pharyngotonsillitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Rhinitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Tonsillitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Bone contusion	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Heat illness	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Blood urine present	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Glucose urine present	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Ocular neoplasm	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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) Skin papilloma	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Cervicobrachial syndrome	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Alopecia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dermatitis	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 1/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Dry skin	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Ingrowing nail	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Pruritus	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hypertension	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 13/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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 Hepatic function abnormal	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.5% 10/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.9% 16/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.0% 8/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.2% 7/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.0% 8/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/79 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/17 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.7% 9/134 • From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) At each visit the investigator had to document any occurrence of adverse events and 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: 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