Methods |
For characteristics see Manns 2012a1
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Central randomisation procedure by an interactive voice‐response system |
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 to investigator and participant |
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 |
Unclear risk |
15 participants dropped out |
Selective reporting (reporting bias) |
Unclear risk |
A protocol was found (NCT00704184), primary objectives were reported correctly, secondary outcomes changed and new exploratory outcomes were reported in the paper |
Vested‐interest bias |
High risk |
This study was funded by Merck Scharp and Dohme Corp. |
Other bias |
Low risk |
The trial appeared to be free of other components that could put it at risk of bias |