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Table 1 Day 28 and Day 42 uncorrected ACPR (steps 1-11) and PCR-corrected ACPR (steps 1-16) in the different populations of analysis

From: Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children

Step Event to be assessed Per Protocol Pure ITT
1 Withdrawal BEFORE OR AT D28: any reason except lost to follow-up Depending on reason, a patient can be excluded or evaluated as Failure Failure
2 Withdrawal BEFORE OR AT D28: lost to follow-up Excluded Failure
3 * Withdrawal AFTER D28: any reason except lost to follow-up Failure Failure
4 * Withdrawal AFTER D28: lost to follow-up Failure Failure
5 ETF, LCF, and LPF in accordance with the WHO criteria Failure Failure
6** Presence of major protocol violations Excluded No effect
7** Occurrence of adverse events highlighting recurrence of malaria Failure Failure
8** Presence of missing parasitaemia at two or more consecutive scheduled visits or presence of an isolated missing parasitaemia not preceded and followed by a negative parasitaemia Failure Failure
9** Administration of drugs with a known or suspected anti-malaria action as rescue treatment Failure Failure
10** Administration of drugs with a known or suspected anti-malaria action as non rescue treatment Excluded Failure
11** Administration of anti-malarial drugs for Plasmodium vivax, Plasmodium malariae, or Plasmodium ovale during the course of the study in patients not classified as ETF or LTF Failure with new infection Failure with new infection
12 PCR not done BETWEEN DAY 4 AND DAY 13 Recrudescence Recrudescence
13 PCR: non interpretable or missing or not done BETWEEN DAY 14 AND D28 Excluded Recrudescence
14** PCR: non interpretable or missing or not done AFTER D28 Rule *** Recrudescence
15 PCR = new infection or uncorrected ACPR = Failure with new infection Success Success
16 PCR = recrudescence Recrudescence Recrudescence
  1. * For the Day 42 endpoint
  2. ** All such cases were individually revised at the Blind Data Review meeting. Protocol violations were pre-defined
  3. *** Patients for whom the PCR is not interpretable or missing will be assigned the result "recrudescence" or "new infection" according to the ratio between these at the corresponding time point and within each treatment group, separately considered