Safety endpoint Adverse events (AEs) were summarized using the safety population, which included all participants who received at least one dose of the study product. All AEs were coded using the Medical Dictionary for Regulatory Activities (v25.1). The number of AEs and serious AEs (SAEs) and the number of participants with AEs/SAEs were tabulated by System Organ Class and Preferred Team. Causality assessment of the AEs was carried out by the virtual research organization prior to database lock.