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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods For characteristics see Bacon 2011a1
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence
Allocation concealment (selection bias) Low risk Allocation of participants through interactive voice‐response system in a 1:2:2 ratio
Blinding of participants and personnel (performance bias) All outcomes Low risk A boceprevir‐matched placebo was used.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk It was not mentioned if the outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes Low risk Treatment discontinuation due to AE was 2% to 12%. Seems no other drop‐outs occurred.
Selective reporting (reporting bias) Low risk A study protocol was published prior to randomisation (NCT00708500). All pre‐specified outcomes were reported on.
Vested‐interest bias High risk Trial was sponsored by a pharmaceutical company (Schering‐Plough/Merck). The company was directly involved in trial design and managing, data analysis, and writing of article.
Other bias Low risk Seems there were no other potential sources of bias.