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. 2019 Feb 7;2019(2):CD012730. doi: 10.1002/14651858.CD012730.pub2

Selby 2007.

Methods Randomized, placebo controlled trial with blinded investigators and patients
Intention to treat not performed
Induction phase 16 weeks in duration, maintenance phase 104 weeks in duration, trial 156 weeks total; all patients were started on a 16‐week tapering course of prednisolone starting at 40 mg/day
Participants Patients over age 18 with active CD (CDAI >200)
(N = 213 for induction phase and N = 122 for maintenance phase)
Interventions Randomized to oral clarithromycin 750 mg/day, oral rifabutin 450 mg/ day, oral clofazimine 50 mg/day (n = 102) or oral placebo (three placebo pills were given to placebo group) (n = 111)
Maintenance phase: antibiotics (n = 67), placebo (n = 55)
Outcomes Primary outcomes: The number of patients who had at least 1 relapse by 52, 104 or 156 weeks
Secondary outcomes: Clinical remission at week 16 (CDAI ≤ 150), relapses within each study phase, time to first relapse, adverse events, endoscopic remission, need for surgery and quality of life
Notes  
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 of participants and personnel (performance bias) 
 All outcomes Low risk Double blind: matched placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Investigators and participants were blinded to treatment allocation. Investigators were more likely to identify those on active treatment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Ninety‐one subjects were withdrawn during the induction phase (56 placebo group, 35 antibiotic group). Reasons included
Selective reporting (reporting bias) Low risk All expected outcomes were reported
Other bias Low risk No other apparent sources of bias