Safety assessments
TEAE
ADVERSE EVENTS, ADVERSE EVENT
We assessed safety by treatment emergent adverse events (TEAEs). TEAEs were collected by the research coordinator at each study visit after genital sampling at baseline and graded for severity using the NIH DAIDS Grading Table for the Severity of Adult and Pediatric Adverse Events (Version 2.1, July 2017) and the Addendum 1, Female Genital Grading Table for Use in Microbicide Studies (Version 1.0, November 2007). Relationship of the TEAE to study product or study procedures was also determined by the study investigators.