Safety
ADVERSE EVENT
Hematological parameters and kidney and liver function were monitored before treatment and on days 7, 14, and 42. At each study visit, participants were clinically assessed by the study physician and safety assessments were performed. All participant-reported AE and SAE were evaluated in relation to VPA and pyrimethamine. Severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. In the study protocol, a number of stopping rules were defined including a prespecified interim analysis after the inclusion of 14 participants focusing on the number of participants discontinuing study medication during the intervention phase, CD4