Figure 1. Enrollment and outcomes for Stage1.

The number of subjects screened, those excluded (due to various medical conditions), those randomized to each treatment, events leading to changes in subject number and the final number of subjects contributing to analyses are indicated. All subjects were included in the full analysis set. Subjects with protocol deviations were excluded from the immunogenicity per-protocol set. Exclusive use of the whole third floor at LMC, facilitated transport and LMC being a primary health provider in Lira and neighboring districts favored high subject compliance rates to clinic visits.