Analysisa | Participants | PCRb‐unadjusted | PCR‐adjusted | ||
Numerator | Denominator | Numerator | Denominator | ||
Primary analysis | Exclusions after enrolment | 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 |