Trial Outcomes & Findings for A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis (NCT NCT00853099)

NCT ID: NCT00853099

Last Updated: 2014-09-05

Results Overview

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore \> 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: * Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal); * Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed); * Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 274 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2014-09-05

Participant Flow

Participant milestones

Measure	Double-blind Placebo Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.	Double-blind Adalimumab 80 mg/40 mg Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	Double-blind Adalimumab 160 mg/80 mg Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	All Adalimumab All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Double-blind Period STARTED	96	87	91	0
Double-blind Period Treated	96	87	90	0
Double-blind Period Completed Week 8	92	85	86	0
Double-blind Period COMPLETED	73	58	60	0
Double-blind Period NOT COMPLETED	23	29	31	0
Double-blind + Open-label Periods STARTED	0	0	0	266
Double-blind + Open-label Periods COMPLETED	0	0	0	119
Double-blind + Open-label Periods NOT COMPLETED	0	0	0	147

Reasons for withdrawal

Measure	Double-blind Placebo Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.	Double-blind Adalimumab 80 mg/40 mg Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	Double-blind Adalimumab 160 mg/80 mg Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	All Adalimumab All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Double-blind Period Adverse Event	7	9	13	0
Double-blind Period Withdrawal by Subject	2	3	0	0
Double-blind Period Lack of Efficacy	14	17	16	0
Double-blind Period Other	0	0	1	0
Double-blind Period Mistreated with rescue study drug	0	0	1	0
Double-blind + Open-label Periods Lack of Efficacy	0	0	0	74
Double-blind + Open-label Periods Adverse Event	0	0	0	47
Double-blind + Open-label Periods Withdrawal by Subject	0	0	0	20
Double-blind + Open-label Periods Other	0	0	0	6

Baseline Characteristics

A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Total n=273 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 13.56 • n=5 Participants	44.4 years STANDARD_DEVIATION 15.04 • n=7 Participants	42.5 years STANDARD_DEVIATION 14.56 • n=5 Participants	42.7 years STANDARD_DEVIATION 14.38 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	37 Participants n=7 Participants	29 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	50 Participants n=7 Participants	61 Participants n=5 Participants	181 Participants n=4 Participants
Region of Enrollment Japan	96 participants n=5 Participants	87 participants n=7 Participants	90 participants n=5 Participants	273 participants n=4 Participants
Mayo score	8.5 scores on a scale STANDARD_DEVIATION 1.56 • n=5 Participants	8.5 scores on a scale STANDARD_DEVIATION 1.42 • n=7 Participants	8.6 scores on a scale STANDARD_DEVIATION 1.44 • n=5 Participants	8.5 scores on a scale STANDARD_DEVIATION 1.47 • n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

• Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
• Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
• Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
• Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Clinical Remission at 8 Weeks	11.5 percentage of participants	13.8 percentage of participants	10.0 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

• Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
• Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
• Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
• Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Clinical Remission at 52 Weeks	7.3 percentage of participants	26.4 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

• Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
• Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
• Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
• Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks Week 8	11.5 percentage of participants	13.8 percentage of participants	10.0 percentage of participants
Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks Week 32	8.3 percentage of participants	17.2 percentage of participants	17.8 percentage of participants
Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks Week 52	7.3 percentage of participants	26.4 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.

The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

• Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
• Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);
• Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
• Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With a Clinical Response Week 8	35.4 percentage of participants	42.5 percentage of participants	50.0 percentage of participants
Percentage of Participants With a Clinical Response Week 32	20.8 percentage of participants	33.3 percentage of participants	37.8 percentage of participants
Percentage of Participants With a Clinical Response Week 52	17.7 percentage of participants	29.9 percentage of participants	31.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.

The endoscopy subscore ranges from zero to three as follows:

0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration).

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Mucosal Healing Week 8	30.2 percentage of participants	39.1 percentage of participants	44.4 percentage of participants
Percentage of Participants With Mucosal Healing Week 32	21.9 percentage of participants	27.6 percentage of participants	31.1 percentage of participants
Percentage of Participants With Mucosal Healing Week 52	15.6 percentage of participants	28.7 percentage of participants	28.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:

0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) Week 8	67.7 percentage of participants	80.5 percentage of participants	71.1 percentage of participants
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) Week 32	28.1 percentage of participants	40.2 percentage of participants	43.3 percentage of participants
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) Week 52	22.9 percentage of participants	32.2 percentage of participants	34.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:

0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) Week 8	44.8 percentage of participants	47.1 percentage of participants	61.1 percentage of participants
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) Week 32	28.1 percentage of participants	36.8 percentage of participants	37.8 percentage of participants
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) Week 52	19.8 percentage of participants	29.9 percentage of participants	34.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:

0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) Week 8	32.3 percentage of participants	34.5 percentage of participants	40.0 percentage of participants
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) Week 32	20.8 percentage of participants	33.3 percentage of participants	31.1 percentage of participants
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) Week 52	13.5 percentage of participants	28.7 percentage of participants	28.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 32, and 52

Population: Full analysis set, non-responder imputation was used.

An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders Week 8	39.6 percentage of participants	48.3 percentage of participants	42.2 percentage of participants
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders Week 32	21.9 percentage of participants	33.3 percentage of participants	28.9 percentage of participants
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders Week 52	12.5 percentage of participants	29.9 percentage of participants	21.1 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: The Safety Analysis Set includes all participants who received at least one dose of study medication.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Number of Participants With Adverse Events up to Week 8 Any adverse event	45 participants	49 participants	40 participants
Number of Participants With Adverse Events up to Week 8 Any AE at least possibly drug related	10 participants	14 participants	12 participants
Number of Participants With Adverse Events up to Week 8 Any serious adverse event	7 participants	2 participants	4 participants
Number of Participants With Adverse Events up to Week 8 Any AE leading to discontinuation of study drug	4 participants	0 participants	6 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: The safety analysis set.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Outcome measures

Measure	Placebo n=96 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg n=87 Participants Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg n=90 Participants Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Number of Participants With Adverse Events up to Week 52 Any adverse event	67 participants	68 participants	75 participants
Number of Participants With Adverse Events up to Week 52 Any AE at least possibly drug related	17 participants	23 participants	32 participants
Number of Participants With Adverse Events up to Week 52 Any serious adverse event	12 participants	14 participants	10 participants
Number of Participants With Adverse Events up to Week 52 Any AE leading to discontinuation of study drug	5 participants	5 participants	12 participants

SECONDARY outcome

Timeframe: 221 weeks

Population: The safety analysis set.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Outcome measures

Measure	Placebo n=266 Participants Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 80 mg/40 mg Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.	Adalimumab 160 mg/80 mg Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Number of Participants With Adverse Events During the Adalimumab Treatment Period Any adverse event	261 participants	—	—
Number of Participants With Adverse Events During the Adalimumab Treatment Period Any AE at least possibly drug related	142 participants	—	—
Number of Participants With Adverse Events During the Adalimumab Treatment Period Any serious adverse event	90 participants	—	—
Number of Participants With Adverse Events During the Adalimumab Treatment Period Any AE leading to discontinuation of study drug	37 participants	—	—

Adverse Events

Double-blind Placebo

Serious events: 13 serious events

Other events: 51 other events

Deaths: 0 deaths

Double-blind Adalimumab 80 mg/40 mg

Serious events: 14 serious events

Other events: 47 other events

Deaths: 0 deaths

Double-blind Adalimumab 160 mg/80 mg

Serious events: 10 serious events

Other events: 60 other events

Deaths: 0 deaths

All Adalimumab

Serious events: 90 serious events

Other events: 235 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-blind Placebo n=96 participants at risk Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.	Double-blind Adalimumab 80 mg/40 mg n=87 participants at risk Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	Double-blind Adalimumab 160 mg/80 mg n=90 participants at risk Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	All Adalimumab n=266 participants at risk All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Cardiac disorders ATRIAL FLUTTER	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Cardiac disorders PERICARDITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Cardiac disorders VENTRICULAR TACHYCARDIA	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Eye disorders DIABETIC RETINOPATHY	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders COLITIS ULCERATIVE	8.3% 8/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.7% 5/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 5/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	14.3% 38/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders COLONIC POLYP	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 3/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders ENTEROCOLITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders GASTROINTESTINAL DYSPLASIA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 3/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders INTESTINAL POLYP	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders RECTAL STENOSIS	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders RECTAL ULCER HAEMORRHAGE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders STOMATITIS	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders ADVERSE DRUG REACTION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders DEATH	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders DRUG INTOLERANCE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders FATIGUE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders MALAISE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations APPENDICITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations BACTERIAL INFECTION	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations BRONCHITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations BURSITIS INFECTIVE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations ENTERITIS INFECTIOUS	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations ERYSIPELAS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations GASTROENTERITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations GINGIVITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations INFECTION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PELVIC ABSCESS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PNEUMONIA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 3/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PSEUDOMEMBRANOUS COLITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations TUBERCULOSIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Injury, poisoning and procedural complications HEAT ILLNESS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Injury, poisoning and procedural complications INTENTIONAL OVERDOSE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Injury, poisoning and procedural complications LIGAMENT INJURY	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Injury, poisoning and procedural complications WOUND	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Investigations DRUG LEVEL	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Investigations MEDICAL OBSERVATION	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 3/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Metabolism and nutrition disorders DECREASED APPETITE	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 3/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.75% 2/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Nervous system disorders EPILEPSY	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Psychiatric disorders DEPRESSION	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Renal and urinary disorders CALCULUS URETERIC	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Renal and urinary disorders TUBULOINTERSTITIAL NEPHRITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Reproductive system and breast disorders CERVICAL DYSPLASIA	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Surgical and medical procedures IMMUNOSUPPRESSANT DRUG THERAPY	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Vascular disorders TAKAYASU'S ARTERITIS	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.38% 1/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.

Other adverse events

Measure	Double-blind Placebo n=96 participants at risk Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.	Double-blind Adalimumab 80 mg/40 mg n=87 participants at risk Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	Double-blind Adalimumab 160 mg/80 mg n=90 participants at risk Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.	All Adalimumab n=266 participants at risk All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	7.3% 7/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.6% 4/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.9% 8/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	9.0% 24/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders COLITIS ULCERATIVE	5.2% 5/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.3% 2/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 5/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	7.5% 20/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders DENTAL CARIES	5.2% 5/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	6.9% 6/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.3% 3/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	10.2% 27/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders NAUSEA	4.2% 4/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.3% 2/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 5/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	9.8% 26/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders STOMATITIS	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.3% 14/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Gastrointestinal disorders VOMITING	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.4% 4/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.6% 23/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders INJECTION SITE REACTION	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.0% 7/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	6.7% 6/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	9.4% 25/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders MALAISE	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	7.8% 7/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.9% 13/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
General disorders PYREXIA	4.2% 4/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.6% 4/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 5/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	9.0% 24/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.3% 14/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations GASTROENTERITIS	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.2% 2/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	6.0% 16/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations INFLUENZA	6.2% 6/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.4% 4/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	7.5% 20/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations NASOPHARYNGITIS	21.9% 21/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	21.8% 19/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	33.3% 30/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	60.9% 162/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations ORAL HERPES	0.00% 0/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.3% 14/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Infections and infestations PHARYNGITIS	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 15/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Investigations WHITE BLOOD CELL COUNT DECREASED	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	6.7% 6/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.3% 22/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.0% 1/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.7% 5/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.2% 2/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	7.9% 21/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Musculoskeletal and connective tissue disorders BACK PAIN	3.1% 3/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.4% 4/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	11.7% 31/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Nervous system disorders HEADACHE	6.2% 6/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	7.8% 7/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	15.8% 42/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Psychiatric disorders INSOMNIA	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.3% 2/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.3% 3/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.6% 23/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	0.00% 0/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	2.2% 2/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	8.6% 23/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Respiratory, thoracic and mediastinal disorders UPPER RESPIRATORY TRACT INFLAMMATION	4.2% 4/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.4% 3/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 5/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	10.2% 27/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Skin and subcutaneous tissue disorders ECZEMA	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.6% 4/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	10.2% 27/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Skin and subcutaneous tissue disorders RASH	5.2% 5/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	4.6% 4/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	3.3% 3/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	10.2% 27/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
Vascular disorders HYPERTENSION	2.1% 2/96 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/87 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	1.1% 1/90 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.	5.6% 15/266 • For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug. Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.

Additional Information

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