| Methods | For characteristics see Silva 2013a1 | |
| Participants | ||
| Interventions | ||
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | computer‐generated random code provided by the sponsor (Schering‐Plough Research Institute) |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The study was described as double‐blinded, (Active drug and matched placebo cap‐sules were used to maintain third‐party blind dispensing) |
| 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 | Only 1 participant dropped out due to AE |
| Selective reporting (reporting bias) | Unclear risk | Protocol not found |
| Vested‐interest bias | High risk | This study was supported by Merck & Co. Inc. |
| Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |
Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.