Trial Outcomes & Findings for Asacol Acute Diverticulitis(DIVA)Study (NCT NCT00554099)

Last Updated: 2013-04-22

Results Overview

GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

117 participants

Primary outcome timeframe

12 Weeks

Results posted on

2013-04-22

Participant Flow

First patient screened 6 Dec 2007

Randomization 1:1:1 ratio with subsequent stratification based on number of prior episodes (1 attack vs. more than 1 attack).

Participant milestones

Participant milestones
Measure	Placebo Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Treatment Period (12 Weeks) STARTED	41	40	36
Treatment Period (12 Weeks) COMPLETED	29	32	27
Treatment Period (12 Weeks) NOT COMPLETED	12	8	9
Non-Treatment Phase (9 Months) STARTED	29	32	27
Non-Treatment Phase (9 Months) COMPLETED	22	27	24
Non-Treatment Phase (9 Months) NOT COMPLETED	7	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Treatment Period (12 Weeks) Adverse Event	3	5	1
Treatment Period (12 Weeks) Physician Decision	3	0	0
Treatment Period (12 Weeks) Lost to Follow-up	1	0	2
Treatment Period (12 Weeks) Recurrent diverticulitis,surgery require	1	2	0
Treatment Period (12 Weeks) Protocol Violation	0	0	2
Treatment Period (12 Weeks) Withdrawal by Subject	4	1	4
Non-Treatment Phase (9 Months) Lost to Follow-up	1	2	0
Non-Treatment Phase (9 Months) Relapse	2	1	1
Non-Treatment Phase (9 Months) Withdrawal by Subject	4	2	2

Baseline Characteristics

Asacol Acute Diverticulitis(DIVA)Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)	Total n=117 Participants Total of all reporting groups
Age, Customized < 65 years	31 Participants n=5 Participants	28 Participants n=7 Participants	25 Participants n=5 Participants	84 Participants n=4 Participants
Age, Customized >= 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	38 Participants n=7 Participants	32 Participants n=5 Participants	107 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	39 Participants n=5 Participants	39 Participants n=7 Participants	33 Participants n=5 Participants	111 Participants n=4 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Asian (Oriental)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Multi-racial	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	41 participants n=5 Participants	40 participants n=7 Participants	36 participants n=5 Participants	117 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population	7.3 Scores on a Scale Standard Error 1.30	4.4 Scores on a Scale Standard Error 1.07	5.9 Scores on a Scale Standard Error 1.16

SECONDARY outcome

Timeframe: 12 Weeks

Population: ITT Population

Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Percentage of Responders at Week 12 - ITT Population	41.4 Percentage of Participants	62.5 Percentage of Participants	48.1 Percentage of Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=32 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=27 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Percentage of Responders at Week 52 - ITT Population	50.0 Percentage of Participants	66.7 Percentage of Participants	29.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Change in GSS From Baseline to Week 12 - ITT Population	-16.14 Scores on a Scale Standard Error 2.082	-17.63 Scores on a Scale Standard Error 1.825	-16.11 Scores on a Scale Standard Error 2.110

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=32 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=27 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Change in GSS From Baseline to Week 52 - ITT Population	-16.82 Scores on a Scale Standard Error 2.527	-17.30 Scores on a Scale Standard Error 2.040	-16.00 Scores on a Scale Standard Error 1.931

SECONDARY outcome

Timeframe: 12 Weeks

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12	2.4 Percentage of Participants	5.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: ITT Population

At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Recurrent Diverticulitis, Percentage, ITT Population, Week 12	20.0 Percentage of Participants	12.5 Percentage of Participants	11.8 Percentage of Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: ITT Population

At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=32 Participants 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=27 Participants 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Recurrent Diverticulitis, Percentage, ITT Population, Week 52	31.0 Percentage of Participants	28.1 Percentage of Participants	37.0 Percentage of Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 32 other events

Deaths: 0 deaths

Mesalamine

Serious events: 5 serious events

Other events: 37 other events

Deaths: 0 deaths

Mesalamine & Probiotic

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Grexan Wulff, Manager Regulatory Affairs

Warner Chilcott

Phone: 973-442-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Placebo n=41 participants at risk Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 participants at risk 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 participants at risk 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Gastrointestinal disorders Abdominal Distension	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Vascular disorders Arterial Thrombosis Limb	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Cardiac disorders Atrioventricular Block	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Ovarian Tumour	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Bronchopneumonia	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Cardiac disorders Cardiac Failure Congestive	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Surgical and medical procedures Colon Operation	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Diverticulitis	4.9% 2/41 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Gastritis	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Intestinal Obstruction	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Pneumonia	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
General disorders Pyrexia	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Renal and urinary disorders Renal Failure Acute	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Nervous system disorders Syncope	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.

Other adverse events
Measure	Placebo n=41 participants at risk Placebo tablets (matching mesalamine, 6 tablets daily)	Mesalamine n=40 participants at risk 400 mg mesalamine (6 tablets daily)	Mesalamine & Probiotic n=36 participants at risk 400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
Respiratory, thoracic and mediastinal disorders Obstructive Airways Disorder	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
General disorders Oedema	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
General disorders Pain	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	8.3% 3/36 • Number of events 3 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.8% 1/36 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Abdominal Pain	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	30.0% 12/40 • Number of events 14 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	11.1% 4/36 • Number of events 5 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Abdominal Pain Lower	7.3% 3/41 • Number of events 4 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	5.6% 2/36 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Abdominal Tenderness	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations Alanine Aminotransferase Increased	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Skin and subcutaneous tissue disorders Alopecia	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Anal Pruritis	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Cardiac disorders Angina Pectoris	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Musculoskeletal and connective tissue disorders Back Pain	4.9% 2/41 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	5.6% 2/36 • Number of events 3 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Reproductive system and breast disorders Bartholin's Cyst	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.7% 1/27 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations Blood Creatinine Increased	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations Blood Pressure Increased	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations Blood Urea Increased	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Bronchitis	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations C-Reactive Protein Increased	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.7% 1/27 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Clostridial Infection	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Surgical and medical procedures Colectomy	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.7% 1/27 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Colonic Polyp	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Constipation	12.2% 5/41 • Number of events 5 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	7.5% 3/40 • Number of events 4 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	8.3% 3/36 • Number of events 3 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Cardiac disorders Coronary Artery Disease	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	5.0% 2/40 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Diarrhoea	4.9% 2/41 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	10.0% 4/40 • Number of events 7 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	8.3% 3/36 • Number of events 3 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Infections and infestations Diverticulitis	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Diverticulum Intestinal	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.7% 1/27 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Investigations Dyslipidaemia	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Dyspepsia	0.00% 0/29 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	3.1% 1/32 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Reproductive system and breast disorders Endometriosis	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.5% 1/40 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
General disorders Fatigue	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	5.6% 2/36 • Number of events 2 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
General disorders Feeling Abnormal	3.4% 1/29 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/32 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/27 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Gastrointestinal disorders Flatulence	2.4% 1/41 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/36 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.
Vascular disorders Flushing	0.00% 0/41 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	0.00% 0/40 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.	2.8% 1/36 • Number of events 1 • 6 Dec 2007 thru 1 Mar 2010 Intent to Treat Population. Adverse Events were differentiated by occurring either in the treatment period (initial 12 weeks therapy) or the non-treatment period (9 month follow up period) using the corresponding numbers from participant flow for each of the trial periods specified.