Participant flow chart.

<p>^aThe reasons why study participants were no longer willing to participate included: no specific reason provided, <i>n</i> = 17; family, social, or personal issues, <i>n</i> = 17; experience of AEs, <i>n</i> = 16; no longer willing to take study drug, <i>n</i> = 6; relocation, <i>n</i> = 3; stillbirth, <i>n</i> = 1. ^bThe reasons why study participants were no longer willing to participate included: family, social, or personal issues, <i>n</i> = 10; relocation, <i>n</i> = 3; no specific reason provided, <i>n</i> = 2. ^cThe AEs leading to discontinuation were combinations of nausea, vomiting, asthenia, spontaneous abortion, imminent abortion, and restlessness. ^dThe AE leading to discontinuation was premature rupture of membranes/stillbirth/umbilical cord abnormality. ^eThe causes of deaths were meningitis; postpartum hemorrhage and uterine rupture; and eclampsia. ^fThe death was due to peritonitis and intestinal perforation. ^gThe ‘other’ reasons for discontinuation were: relocation, <i>n</i> = 9; family, social, or personal issues, <i>n</i> = 5; non-compliance with study procedures, <i>n</i> = 2. ^hThe ‘other’ reasons for discontinuation were: relocation, <i>n</i> = 5; family, social, or personal issues, <i>n</i> = 5; no specific reason provided, <i>n</i> = 1.</p

Overview of adverse events in the safety population.

<p>Overview of adverse events in the safety population.</p

Study Design.

<p>ITT, intent-to-treat; MITT, modified ITT; PP, per protocol.</p

Most common serious adverse events in the safety population.

<p>Most common serious adverse events in the safety population.</p

Baseline characteristics in the safety population.

<p>Baseline characteristics in the safety population.</p

Summary of drug concentrations (ng/ml).

<p>Summary of drug concentrations (ng/ml).</p

Kaplan-Meier estimates of the percentage parasitological responders at days 7–42 in the PP analysis population.

<p>Kaplan-Meier estimates of the percentage parasitological responders at days 7–42 in the PP analysis population.</p

Summary of neonate outcomes at birth in the safety population.

<p>Summary of neonate outcomes at birth in the safety population.</p

Crude estimates of parasitological responders at days 28 and 42 in the PP analysis population.

<p>Crude estimates of parasitological responders at days 28 and 42 in the PP analysis population.</p

All-causality treatment-emergent adverse events occurring in ≥5 mothers.

<p>All-causality treatment-emergent adverse events occurring in ≥5 mothers.</p