Methods |
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random number table. |
Allocation concealment (selection bias) |
Low risk |
Central administration of blinded drug containers. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind placebo‐controlled with additional blinded data analyses. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All participants accounted for. |
Selective reporting (reporting bias) |
Low risk |
Clinically relevant outcome measures defined and reported. |
Sample size calculations |
Unclear risk |
Not reported. |