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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Mayo 2015.

Methods Randomised clinical trial.
Participants Country: multicentric; international.
Number randomised: 45.
Post‐randomisation dropouts: 3 (6.7%).
Revised sample size: 42.
Mean age: 56 years.
Females: 38 (90.5%).
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: not stated.
Mean follow‐up period (for all groups): not stated.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: NGM282 (n = 27).
Further details: NGM282: 0.3 mg/day or 3 mg/day SC for 28 days.
Group 2: placebo (n = 15).
Outcomes None of the outcomes of interest reported.
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 Unclear risk Comment: although placebo was used in this 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 this double‐blind trial, unclear whether the placebo was identical.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias) High risk Comment: neither mortality nor adverse events reported.
For‐profit bias High risk Quote: "Grant/Research Support: Intercept, Salix, NGM, Lumena, Gilead".
Other bias Low risk Comment: no other bias.