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Lcer was identified, and 5.6 had 1 STI examination during which a groin ulcer was identified after HIV seroconversion, and thus after stopping study drug. The proportions with each type of ulcer did not differ between participants in the FTC/TDF arm and participants in the placebo arm. Finally, the iPrEx protocol did not use the HSV-2 test manufacturer's suggested cutoffs for indeterminate (IR

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N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f

Es would most likely not have been affected. The measures of immune activation were not assessed at enrollment into the study cohort, and we therefore cannot make temporal inferences of a causal nature nor could we control for them in the multivariable Cox models. We used prevalence rate ratios (PRRs) to estimate the associations of interest as risk was our parameter of interest. We chose PRRs as