Methods |
For characteristics see Dauphine 2015a2
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation |
Allocation concealment (selection bias) |
Unclear risk |
Not described |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
Unblinded |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Unblinded |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
There were above 5 % drop outs and it was unclear how the trial handLed the missing participants |
Selective reporting (reporting bias) |
Low risk |
All outcomes stated in the protocol were reported on: NCT01220947
|
Vested‐interest bias |
High risk |
The trial was funded by F. Hoffmann‐La Roche Ltd |
Other bias |
Low risk |
The trial appeared to be free of other components that could put it at risk of bias |