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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods Randomised clinical trial
Participants 54 participants
Country: USA
Inclusion criteria: Adult treatment‐naive participants in genotype 1 HCV participants.
Interventions Experimental group: oral 25 mg, 75 mg, or 200 mg of GS‐9256 twice daily, or 300 mg of GS‐9256 once daily for 3 days.
Control group: placebo.
Outcomes Safesty assessment, HCV RNA level, pharmacokinetics.
Notes We emailed Lawitz and colleagues on 26 April 2016 for additional information on random, blinding, missing data, protocol, data, participants characteristics, funding, number of participants in placebo/exp group but reply not received yet.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Described as double‐blinded, but it was not described how blinding was performed
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Described as double‐blinded, but it was not described how blinding was performed
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not described
Selective reporting (reporting bias) Unclear risk No protocol could be obtained
Vested‐interest bias High risk Several authors worked for Gilead Sciences
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias