2. Primary outcome measure (Total failure).
Analysis | Participants | PCRb‐unadjusted | PCR‐adjusted | ||
Numerator | Denominator | Numerator | Denominator | ||
Primary analysis | Exclusions after enrolmenta | Excludedc | Excluded | Excluded | Excluded |
Missing or indeterminate PCR | Included as failures | Included | Excluded | Excluded | |
New infections | Included as failures | Included | Excluded | Excluded | |
Sensitivity analysis 1d | As 'Primary analysis' except: missing or indeterminate PCR | — | — | Included as failures | Included |
Sensitivity analysis 2e | As 'Sensitivity analysis 1' except: new infections | — | — | Included as successes | Included |
Sensitivity analysis 3f | As 'Sensitivity analysis 2' except: exclusions after enrolment | Included as failures | Included | Included as failures | Included |
Sensitivity analysis 4g | As 'Sensitivity analysis 2' except: exclusions after enrolment | Included as successes | Included | Included as successes | Included |
aNote: participants who were found to not satisfy the inclusion criteria after randomization are removed from all calculations. bPCR: polymerase chain reaction. c'Excluded' means removed from the calculation. dTo re‐classify all indeterminate or missing PCR results as treatment failures in the PCR‐adjusted analysis. eTo re‐classify all PCR‐confirmed new infections as treatment successes in the PCR‐adjusted analysis. (This analysis may overestimate efficacy as PCR is not wholly reliable and some recrudescences may be falsely classified as new infections. Also some participants may have proceeded to develop a recrudescence after the new infection.) fTo re‐classify all exclusions after enrolment (losses to follow‐up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment failures. For PCR‐unadjusted total failure, this represents a true worse‐case scenario. gTo re‐classify all exclusions after enrolment (losses to follow‐up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment successes.