Listing of clinical laboratory adverse events experienced by study participants.
(DOCX)Click here for additional data file.We thank the study participants for their cooperation throughout the trial; the study team in Brazil, especially Cássia Senra, Simone Pinto, Stella Sobrinho, Ana Raquel Godoy, Fernanda Gambogi, and Roberta Rodrigues; Christiane Correa Rodrigues Cimini for being the independent safety monitor; and, Arthur Clinton White, Jr., Thomas Richie, and Kirsten Lyke for serving as members of the independent study Safety Monitoring Committee.