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Internal validity
| Study 1 | Study 2 | |
| Power calculation | ||
| Randomisation methods | ||
| Stratification at randomisation | ||
| Allocation concealment | ||
| Inclusion/exclusion criteria stated | ||
| Group similarity at baseline | ||
| Outcome assessment blinded | ||
| Investigators blinded | ||
| Participants blinded | ||
| Objective outcome criteria | ||
| ITT analysis | ||
| Protocol deviations | ||
| All participants accounted for | ||
| Withdrawals specified | ||
| Withdrawal reasons given | ||
| Intercentre consistency | ||
| Conflict of interest |
ITT: intention‐to‐treat
