Kwo 2010a3

Methods	For characteristics see Kwo 2010a1
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random code
Allocation concealment (selection bias)	Low risk	Allocation performed by an external randomisation centre through interactive voice‐response system in 1:1:1:1:1 ratio. Randomisation was stratified according to race (black vs non‐black) and cirrhosis status (cirrhosis vs no cirrhosis)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Trial described as open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Trial described as open‐label
Incomplete outcome data (attrition bias) All outcomes	High risk	Although number and reasons for withdrawal were clearly stated, the proportion of participants who discontinued treatment was high, from 26% to 50%, mostly due to AEs or treatment inefficiency
Selective reporting (reporting bias)	High risk	Although a protocol was available and published before randomisation began, number of SAE were differently stated in the published article compared to data presented on www.ClinicalTrials.gov. Data presented in the latter were somewhat higher. Data reported are from www.ClinicalTrials.gov
Vested‐interest bias	High risk	The sponsor of the study contributed to patient recruitment, trial management, data collection, statistical analyses, and the writing and review of the report
Other bias	Low risk	The trial appeared to be free of other bias domains that could put it at risk of bias