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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