2.3. Safety
ADVERSE EVENTS
The safety population (SAF) consisted of all participants who received at least 1 dose of the study product. Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) with the onset time on or after the first dose of the study product. The number and percentage of participants and TEAEs are summarized based on Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), Preferred Term (PT), severity, and relationship to the study product by study arm. The relationship between the study intervention and each AE was assessed by the study clinician using their best judgment by examining and evaluating the participant based on the temporal relationship to the AE.