Nishiguchi 2014a2

Methods	For characteristics see Nishiguchi 2014a1
Participants
Interventions
Outcomes
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The trial used a "pseudo‐random number generator and supplied seed number" to generate the allocation sequence
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	The trial was only blinded up to week 8
Blinding of outcome assessment (detection bias) All outcomes	High risk	The trial was only blinded up to week 8
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There was above 5% dropouts and it was unclear how the trial accounted for missing data
Selective reporting (reporting bias)	High risk	The secondary outcomes were changed after the trial was completed (NCT00947349)
Vested‐interest bias	High risk	The trial was supported by a company that might have an interest in a given result (Boehringer Ingelheim)
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias