Lindor 1994.

Methods	Randomised clinical trial.
Participants	Country: USA. Number randomised: 180. Post‐randomisation dropouts: 10 (5.6%). Revised sample size: 170. Mean age: 53 years. Females: 160 (94.1%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 24 months. Inclusion criteria Symptom status: symptomatic and asymptomatic participants. AMA status: not stated. Response status: not stated. Exclusion criteria People with decompensated cirrhosis. Hepatocellular carcinoma. Concomitant immunosuppressive regimen. Other major diseases unrelated to primary biliary cholangitis. Alcohol abuse. Low compliance. Recurrent variceal haemorrhage, intractable ascites, spontaneous encephalopathy.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) (n = 86). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated. Group 2: placebo (n = 84).
Outcomes	Mortality, adverse events, liver transplantation.
Notes	Reasons for post‐randomisation dropouts: not stated.
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	Low risk	Quote: "The patients, physicians, nurses, and study coordinators were blinded as to whether active drug or placebo was being administered".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The patients, physicians, nurses, and study coordinators were blinded as to whether active drug or placebo was being administered".
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias)	Low risk	Comment: mortality and morbidity reported.
For‐profit bias	High risk	Quote: "Supported by Falk Pharma and Interfalk".
Other bias	Low risk	Comment: no other risk of bias.