| 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 | |
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