Bronowicki 2013a2

Methods	For characteristics see Bronowicki 2013a1
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	It was stated that "Investigators and participants were blinded to treatment assignment throughout the study" but it was not stated how the blinding was maintained.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The sponsor was blinded to treatment assignment until the primary end point analysis which was at 12 weeks and we used data at week 24.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	It was unclear how many participants had missing data and how the trial handled participants with missing data
Selective reporting (reporting bias)	Low risk	All outcomes stated in the pre published protocol (NCT01030432) were reported
Vested‐interest bias	High risk	The study was funded by Bristol‐Myers Squibb
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias