3.5. Safety
treatment-emergent adverse events, TEAEs, Treatment-emergent adverse
EVENTS
Overall, there were similar incidences of treatment-emergent adverse events (TEAEs) in treatment and placebo arms. Thirty-three participants experienced 56 TEAEs during the study period (Treatment-emergent adverse events (TEAEs) in the full analysis set (FAS) population were neither serious nor fatal, and no TEAE led to study discontinuation. Participant numbers in the Severity and Relationship columns exceed the number in the Overall column because some participants experienced multiple events with discrete severity and/or relationship to the interventions. The majority of TEAEs were determined to be unrelated to the interventions, while less than a third were possibly related to the interventions, and no TEAEs were definitively related to the interventions.