Maximum systemic reactogenicity.

*For each systemic reactogenicity outcome except nausea and vomiting (NS: not significant), a statistically significant difference was found among the three treatment arms (Kruskal-Wallis p ≤0.01; values not shown). For those outcomes showing an overall significant difference, unadjusted p values specifically for 1010 PU vs. 1011 PU arms (shown in table) were subsequently calculated. All of these are significant after applying Simes procedure to control the false discovery rate at 0.05 to account for the multiple comparisons.
**Severity definitions are given in the HVTN Table for Grading Severity of Adverse Experiences (Revised Sep 2002); see also Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (December, 2004). In general, mild systemic reactions are those causing no or minimal interference with usual social and functional activities; moderate reactions cause greater than minimal interference with such activities; and severe reactions cause inability to perform such activities.