Statistical analysis The primary outcome was the PCR-adjusted parasitological cure rate up to day 42 of the follow-up period. Two analytical approaches were used to assess efficacy data. First a per protocol (PP) analysis was performed including only the patients who were followed throughout the protocol, defined follow-up period and in whom a clear treatment outcome can be determined. The risk of failure for each treatment group was calculated as the proportion of patients classified as failure (the numerator) divided by the number of patients in the evaluable population (the denominator). In the second approach, survival analysis was performed and patients with incomplete follow-up who did not reach the primary outcome interest were included in the analysis as non-failures, but censored on the last day of follow-up. The risk of failure was calculated using the Kaplan-Meier product limit formula with data censored for patients who were not classified as failures and with interrupted follow-up. Patients wrongly included, who did not meet study inclusion criteria, were excluded from both analyses.