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. 2020 Aug 12;2020(8):CD000543. doi: 10.1002/14651858.CD000543.pub5

D'Haens 2017.

Study characteristics
Methods Randomized, active‐controlled, multicenter, non‐inferiority induction trial
Participants Adults (18 years and older) diagnosed with mild‐to‐moderate ulcerative colitis (N = 817)
Interventions Participants received 3.2 g of oral mesalazine administered as 2 x 1600 mg tablets each morning or 4 x 400 mg tablets taken twice daily for 8 weeks
Outcomes Primary outcome: The proportion of participants in clinical and endoscopic remission at week 8
Secondary outcomes: Endoscopic remission, endoscopic response, clinical remission at week 8, rectal bleeding subscore of 0 at week 8, clinical and endoscopic response at week 8, clinical remission at week 12, clinical response at week 12, rectal bleeding subscore of 0 at week 12, clinical remission at weeks 8 and 10 and 12, clinical response at weeks 8 and 12
Notes Study was funded by Tillotts Pharma, AG.
Author conflicts of interest are reported in the manuscript
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomization schedule was generated by computer in permuted blocks of 6 without stratification
Allocation concealment (selection bias) Low risk An interactive web response system was used to manage randomization and dispense the study drug
Blinding (performance bias and detection bias)
All outcomes Low risk All participants took the same numer of identical‐looking 1600 mg or 400 mg placebo tablets. Investigators, central readers and participants were unaware of the participant assignment
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants involved in the trial were accounted for with reasons
Selective reporting (reporting bias) Low risk Expected outcomes were reported in the published study
Other bias Low risk The study appears to be free from other sources of bias