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
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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). |
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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. |