Nelson 2012a2

Methods	For characteristics see Nelson 2012a1
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The computerised randomisation list was generated by the sponsor, maintained in a central repository accessible only to the randomisation list managers, and incorporated in double‐blind labelling of medication containers
Allocation concealment (selection bias)	Low risk	The computerised randomisation list was generated by the sponsor, maintained in a central repository accessible only to the randomisation list managers, and incorporated in double‐blind labelling of medication containers
Blinding of participants and personnel (performance bias) All outcomes	High risk	All participants were unblinded to their treatment assignment and, among those who received balapiravir and who had a CD4+ count < 200 cells/mm3, treatment with peg‐IFN alfa‐2a (40KD) and RBV was permanently discontinued
Blinding of outcome assessment (detection bias) All outcomes	High risk	All participants were unblinded to their treatment assignment and, among those who received balapiravir and who had a CD4+ count < 200 cells/mm3, treatment with peg‐IFN alfa‐2a (40KD) and RBV was permanently discontinued
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was more than 5% dropouts and it was unclear how the trial accounted for missing data
Selective reporting (reporting bias)	High risk	Relapse rate was not reported on despite being stated as an outcome in the protocol (NCT 00517439).
Vested‐interest bias	High risk	The trial was supported by a company with an interest in a given result (Hoffmann‐La Roche)
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias