Bowlus 2014.

Methods	Randomised clinical trial.
Participants	Country: multicentric; international. Number randomised: 216. Post‐randomisation dropouts: not stated. Revised sample size: 216. Mean age: 56 years. Females: 197 (91.2%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 12 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: not stated.
Interventions	Participants were randomly assigned to 3 groups. Group 1: obeticholic acid (low) (n = 73). Further details: obeticholic acid (low): 5 mg orally for 12 months; frequency not stated. Group 2: obeticholic acid (low) (n = 73). Further details: obeticholic acid (low): 10 mg orally for 12 months; frequency not stated. Group 3: placebo (n = 70).
Outcomes	None of the outcomes of interest reported.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: information not available.
Allocation concealment (selection bias)	Unclear risk	Comment: information not available.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: although placebo was used in double‐blind trial, unclear whether the placebo was identical.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: although placebo was used in double‐blind trial, unclear whether the placebo was identical.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: information not available.
Selective reporting (reporting bias)	High risk	Comment: neither mortality nor adverse events reported.
For‐profit bias	High risk	Comment: Several authors had advised pharmaceutical companies or were employees of pharmaceutical company.
Other bias	Low risk	Comment: no other source of bias.