| Methods | For characteristics see Rodriguez‐Torres 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) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study was described as double‐blinded, but it was unclear how the blinding was maintained |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study was described as double‐blinded but it was unclear how the blinding was maintained and who performed the outcome assessment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 participants dropped out (5.4%) due to administrative discontinuations |
| Selective reporting (reporting bias) | Low risk | A protocol was found (NCT00704405) and all outcomes reported on |
| Vested‐interest bias | High risk | This study was sponsored and funded by Merck |
| 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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