Safety was assessed through a review of reported adverse occasions and abnormal laboratory-test outcomes. At each study visit, individuals were asked to complete the Columbia Suicide Severity Rating Scale for suicidal behavior or ideation. Statistical Analysis We calculated a sample of 750 patients would provide sufficient power for the proposed tests in this four-group study . Adjustments from baseline to week 12 in the IRLS rating were analyzed with a linear blended model and the use of a spatial-power covariance structure.Santos, M.D., Kenneth H. Mayer, M.D., Irving F. Hoffman, P.A., Susan H. Eshleman, M.D., Estelle Piwowar-Manning, M.T., Lei Wang, Ph.D., Joseph Makhema, F.R.C.P., Lisa A. Mills, M.D., Guy de Bruyn, M.B., B.Ch., Ian Sanne, M.B., B.Ch., Joseph Eron, M.D., Joel Gallant, M.D., Diane Havlir, M.D., Susan Swindells, M.B., B.S., Heather Ribaudo, Ph.D., Vanessa Elharrar, M.D., David Burns, M.D., Taha E. Taha, M.B., B.S., Karin Nielsen-Saines, M.D., David Celentano, Sc.D., Max Essex, D.V.M., and Thomas R. Fleming, Ph.D. For the HPTN 052 Study Team: Prevention of HIV-1 Infections with Early Antiretroviral Therapy Combination antiretroviral therapy reduces the replication of human immunodeficiency virus type 1 and improves the survival of infected persons.1,2 Such therapy has been proven to reduce the quantity of HIV-1 in genital secretions.3-5 As the sexual transmission of HIV-1 from infected persons to their companions is strongly correlated with concentrations of HIV-1 in blood6 and in the genital tract,7 it’s been hypothesized that antiretroviral therapy could reduce sexual transmission of the virus.