Table 3.

Efficacy evaluation on Day 28 after PCR correction* ITT and PP analysis

	AL (N = 665)	AS+AQ (N = 619)	AS+SP (N = 678)	P value
Possible failure* – n (%)	31 (4.7)	18 (2.9)	11 (1.6)	0.005
ETF† – n (%)	0 (0)	1 (0.2)	0 (0)	0.32
LCF† – n (%)	2 (0.3)	1 (0.2)	0 (0)	0.43
LPF† – n (%)	4 (0.6)	6 (1.0)	3 (0.4)	0.5
ITT–ACPR – n (%)	628 (94.4)	593 (95.8)	664 (97.9)	0.004
PP–ACPR – n/N (%)	628/634 (99.1)	593/601 (98.7)	664/667 (99.6)	0.25
Reinfection rate – n/N (%)	231/634 (36.4)	117/601 (19.5)	62/667 (9.3)	< 0.001

^*Possible failure: lost to follow-up or withdrawal or subjects for which filters were missing or undetermined PCR.

^†These are computed according to ITT analysis.

PCR = polymerase chain reaction; ITT = intention-to-treat; PP = per protocol; AL = artemether-lumefantrine; AS+AQ = artesunate plus amodiaquine; AS+SP = artesunate plus sulfadoxine-pyrimethamine; n/N = frequency; ETF = early treatment failure; LCF = late clinical failure; LPF = late parasitological failure; ACPR = adequate clinical and parasitological failure.