D'Haens 2006.

Study characteristics
Methods	Randomized, multicenter, double‐blind, parallel‐group, dose‐ranging study
Participants	Adultss (aged > 18 years) with histologically‐confirmed, newly‐diagnosed or relapsing mild to moderately‐active ulcerative colitis (N = 38)
Interventions	MMX mesalazine (SPD476) 1.2 (n = 13), 2.4 (n = 14) or 4.8 g/day (n = 11), given once daily for 8 weeks
Outcomes	Primary outcome: remission defined as a UC‐DAI score < 1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1‐point reduction from baseline in sigmoidoscopy score. Secondary outcomes: change in UC‐DAI score, sigmoidoscopic appearance and histology from baseline to week 8, and the change in symptoms (rectal bleeding and stool frequency) from baseline to weeks 2, 4 and 8 for the 3 dose groups
Notes	Study was funded by Shire Pharmaceuticals Inc. Conflicts of interest were not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind: MMX mesalazine and placebo tablets were identical in appearance
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The 1.2 g/day group had 6 withdrawals (6/13) compared to 3 (3/14) in the 2.4 g/day and 1 (1/11) in the 4.8 g/day groups. LOCF was used to address incomplete outcome data
Selective reporting (reporting bias)	Low risk	Expected outcomes were reported
Other bias	Low risk	The study appears to be free of other sources of bias