Table 3.

Incidence rate of ABR Wave III latency changes > 0.30 msec from baseline over time (per protocol populations)^*

	Artemether-lumefantrine	Atovaquone-proguanil	Artesunate-mefloquine
Day 3	N = 145	N = 50	N = 45
	4 (2.8)	0	0
	[0.8–6.9]	[0.0–7.1]	[0.0–7.9]
Day 7 (primary endpoint)†	N = 151	N = 50	N = 45
	4 (2.6)‡	0	0
	[0.7–6.6]	[0.0–7.1]	[0.0–7.9]
Day 28	N = 143	N = 50	N = 46
	6 (4.2)	1 (2.0)	0
	[1.6–8.9]	[0.1–10.6]	[0.0–7.7]
Day 42	N = 138	N = 49	N = 47
	4 (2.9)	0	1 (2.1)
	[0.8–7.3]	[0.0–7.3]	[0.1–11.3]

^*Data are presented as n (%) [Exact Pearson-Clopper 95% confidence interval].

ABR = auditory brainstem response; N = number of patients in the respective per-protocol population

^†Based on a review by an independent audiologist (fully blinded).

^‡P < 0.0001 for the one-sided null hypothesis that the incidence rate of ABR Wave III latency change is ≥ 15% in the artemether-lumefantrine group.