Statistical methods & data management
parasitaemia
REGRESSION, RECURRENCE, G6PD DEFICIENCY
Data were entered from standardised case record forms and analysed using Stata v16.0 (StataCorp, College Station, TX). Negative binomial regression adjusted for follow up time was used to estimate the incidence rate of recurrence outcomes and Kaplan Meier survival estimates were used to assess the incidence risk of recurrent parasitaemia. Descriptive statistics are presented for haematological outcomes. All patients who received at least one dose of study drug were included in the efficacy and safety analyses. Estimates of safety and efficacy outcomes are provided with 95% confidence intervals but no statistical comparison is made between these estimates in the patients treated with weekly primaquine and those in main randomised trial. Since only eligible patients agreeing to be enrolled into the IMPROV study were tested for G6PD deficiency, reliable estimates of the background prevalence of G6PD at each of the sites were not available. Handling of missing data and adjudication of outcomes are described in detail in the 