de Jong 2007.

Methods	Randomized, double‐blind, parallel group, multicenter trial
Participants	Patients 18‐75 years old with CD confined to ileum or colon in remission for 3‐18 months (N = 157) METHOD OF INDUCTION OF REMISSION: Any, except no small bowel resections > 80 cm within 6 months of enrollment (remission defined as CDAI < 150) EXCLUSION CRITERIA: 1) Rectal or perianal disease, 2) Bowel surgery within 6 months of enrollment, 3) History of small bowel resections >80 cm, 4) Disease locations proximal to ileum, 5) Severe hepatic/renal disease, 6) Contraindication to corticosteroids, 7) Need for parenteral nutrition, 8) Presence of active infection, 9) Pregnancy or inadequate use of contraception
Interventions	Group 1: pH‐modified release budesonide (Budenofalk) 6 mg once daily for 52 weeks (n = 76) Group 2: pH‐modified release budesonide (Budenofalk) 9 mg once daily for 52 weeks (n = 81)
Outcomes	1) Relapse of disease (defined as CDAI > 150 and an increase of at least 60 points from baseline) 2) Time to relapse 3) Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomized using a computer‐generated list
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes were used to assign treatment
Blinding (performance bias and detection bias) All outcomes	Low risk	Described as double blind Appearance of placebo was identical to that of the study mediation Blinding of outcome assessors was not described; however, the primary outcome (based on the CDAI) is predominately based on patient reports (diary) and is consequently at low risk of bias
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withdrawals were similar across groups
Selective reporting (reporting bias)	Low risk	All key outcomes included
Other bias	Low risk	No additional sources of bias were identified