| Methods | For characteristics see OPERA 2011a1 | |
| 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 | Randomisation was achieved using the central interactive web response system, managed by ClinPhone Group Ltd |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blinded and placebo described as identical |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 5 participants were not included in the intention‐to‐treat analysis resulting in under 5% with missing data. |
| Selective reporting (reporting bias) | Low risk | All outcomes in the protocol were reported on |
| Vested‐interest bias | High risk | This study was sponsored by Tibotec Pharmaceuticals |
| 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.