| Methods | For characteristics see Rodriguez‐Torres 2014b1 | |
| 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 | All sponsor personnel responsible for the conduct of the trial, with the exception of the sponsor study programmer, remained blinded to the results provided to the data monitoring committee. (Participants and investigators were unblinded to treatment assignment at week 24 to determine eligibility to discontinue therapy) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 67 participants dropped out |
| Selective reporting (reporting bias) | Low risk | A protocol was found (NCT00987337) and the outcomes reported |
| Vested‐interest bias | High risk | This study was sponsored by Pfizer Inc. |
| 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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