| Methods | For characteristics see Izumi 2014a1 | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Central randomisation centre |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded after week 24 |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded after week 24 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 person dropped out |
| Selective reporting (reporting bias) | High risk | The trial changed the primary outcomes |
| Vested‐interest bias | High risk | The trial 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 |
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