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Figure 1.

Study location.

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Table 1.

Safety Outcomes and Assessments.

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Figure 2.

Enrollment, randomization and workflow.

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Table 2.

Baseline Characteristics in 143 Patients; intention to treat analysis.

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Table 3.

Clinical and parasitological responses in 143 patients with acute P.falciparum malaria receiving artesunate monotherapy: intention to treat analysis.

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Figure 3.

Modified intention-to-treat analysis: outcome measured to 42 days.

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Table 4.

Outcome: per protocol analyses in patients at 28 (n = 136) and 42 (n = 133) days; P. vivax cases occurring during follow-up not removed.

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Table 5.

Outcome: per protocol analysis in 109 patients at 42 days; P. vivax relapse cases censored from analysis.

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Table 6.

Individual data for patients with reappearance of Plasmodium falciparum parasites during follow-up and median (IQR) values for cured subjects in the three dosing arms.

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Figure 4.

Modified intention-to-treat analysis: proportion of patients remaining parasitemic by treatment arm.

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Table 7.

Parasitological, clinical and in vitro responses in early treatment failures, recrudescent and cured patients; data expressed as median (IQR) unless otherwise stated.

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Table 8.

Comparison of clinical and parasitological outcomes with other published data (Dondorp, 2009).

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Table 9.

Comparison of clinical, parasitological and laboratory parameters of patients with rapid or slow parasite clearance.

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Table 10.

Comparison of baseline and pharmacokinetic parameters with other published data (Dondorp, 2009).

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Figure 5.

IC50 values at baseline using HRP2 methodology in fresh cultured parasite isolates from 131 patients.

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