4. STATISTICAL ANALYSIS The primary outcome and the safety data were analyzed on a modified intention-to-treat population. A conservative analysis will be repeated on the per protocol population excluding patients with subsequent major protocol violations. The primary outcome will be the proportion of therapeutic failure observed up to day 28 of follow-up in each study arm. The investigators will compare the cumulative incidence of P. vivax recurrence between study arms. SPSS version 17.0 will be used for data management and analysis. Data will be analyzed by Kaplan-Meier (KM) method and per-protocol analysis. The time to the first parasite recurrence within 28 days of follow-up (primary outcome) and between days 29 and 180 (secondary outcome) will be calculated using KM estimates (survival analysis). Statistical comparisons will be made between the arms using the log rank test. The proportions of clinical and parasitological failure, and adequate clinical and parasitological response at day 28 will be calculated, with their respective 95% confidence intervals.