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. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927

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 fTo re‐classify all exclusions after enrolment (losses to follow‐up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment failures.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 gTo re‐classify all exclusions after enrolment (losses to follow‐up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment successes.