| Methods |
See aa Hoberman 2003a
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Funding Source |
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number, computer‐generated list, block randomisation (block of 9) |
| Allocation concealment (selection bias) |
Low risk |
"Randomisation lists were kept in locked files not accessible to blinded personnel" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate. |
| Summary assessments |
Low risk |
|
