Figure 1

Patients enrolled and analyzed. ITT, intention-to-treat; MITT, Microbiological intention-to-treat. *Prior to study termination the Marketing Authorization Holder for the study identified five study sites (three in Guatemala, one in Germany, one in the United States), following independent internal reviews and re-monitoring by a contract research organization (CRO), that were found not to have adhered to the study protocols, or the study logs could not verify protocol adherence, and thus their data were excluded from the primary analyses.