Table 3.

Primary Efficacy Results.

Result	Oral TDF*		Oral TDF-FTC	Oral Placebo	TFV Gel	Placebo Gel
	Active Agent	Placebo
Person-years	823	838	1284	1308	1024	1030
Number of HIV-1 infections	52	35	61	60	61	70
HIV-1 incidence — cases per 100 person-years (95% CI)	6.3 (4.7–8.3)	4.2 (2.9–5.8)	4.7 (3.6–6.1)	4.6 (3.5–5.9)	6.0 (4.6–7.6)	6.8 (5.3–8.6)
Hazard ratio (95% CI)	1.49 (0.97–2.29)	—	1.04 (0.73–1.49)	—	0.85 (0.61–1.21)	—
P value	0.07	—	0.81	—	0.37	—

^*Data were censored on the date when sites were asked to discontinue treatment in the oral TDF group.