Hellers 1999.

Methods	Randomized, parallel‐group, double‐blind, placebo‐controlled, multicenter trial
Participants	Patients scheduled for surgical resection of ileocolonic CD (N = 130) METHOD OF INDUCTION OF REMISSION: Surgical resection of diseased area EXCLUSION CRITERIA: 1) Previous ileal resection > 100 cm, 2) Infectious complication such as abscess or fistula, 3) Corticosteroids less than 30 days from surgery, 4) Any medication for treatment of CD (except budesonide)
Interventions	Group 1: CIR budesonide (Entocort) 6 mg once daily for 52 weeks (n = 63) Group 2: Placebo for 52 weeks (n = 67)
Outcomes	1) Proportion of patients with disease in remission defined as CDAI < 150 at specific time points 2) Recurrence of disease defined by a score of 2 or higher on the Rutgeerts scale (Rutgeerts 1990) 3) CDAI score (note: baseline CDAI was taken 6 weeks after surgical resection to induce remission) 4) ACTH stimulation test (normal response defined as baseline plasma cortisol concentration > 150 nmol/L and a concentration of > 400 nmol/L or an increase of at least 200 nmol/L at 30 or 60 minutes).
Notes	Additional unpublished data obtained from study sponsor
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description provided
Allocation concealment (selection bias)	Unclear risk	No description provided
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The study is described as double blind; however, no description is provided with regard to the mechanisms to ensure the blinding of participants and outcome assessors (endoscopists)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withdrawals similar across groups
Selective reporting (reporting bias)	Low risk	All key outcomes were included
Other bias	Low risk	No additional sources of bias were identified