Data Analyses
Subjects with posttreatment viral RNA rebound were identified based on an increase in viral RNA levels from day 5 to day 10 or day 14 (Exploratory statistical analyses were conducted using two-sided Fisher’s exact tests to provide nominal p-values, without multiplicity adjustments; p<0.05 was considered statistically significant. Analyses were conducted using JMP (version 16; SAS Institute). This study was reviewed by the FDA Institutional Review Board and deemed not to constitute research involving human subjects as defined in 45 CFR part 46.