Figure 1.

Randomization of Patients and the Analysis Populations.

A total of five women were excluded after the receipt of the first dose of study medication because of entry-criteria violations. The exclusions from the intention-to-treat population (blue) and the per-protocol population (yellow-green) are based on the efficacy population. The intention-to-treat population excluded women who were lost to follow-up, died, withdrew, or had missing or indeterminate results on polymerase-chain-reaction assay; however, these women were included in the intention-to-treat analyses that used multiple imputations. The per-protocol population also excluded persons with major protocol violations, defined as a violation of the inclusion or exclusion criteria, receipt of a treatment different from the randomly assigned one, missing at least a full day of treatment, intake of other drugs with antimalarial activity, and missing day 63 blood smears.