Safety and tolerability assessments
ADVERSE EVENTS, ADVERSE EVENT
Safety evaluation included monitoring of adverse events (AEs) and serious AEs (SAEs), clinical laboratory tests (hematology, clinical chemistry, and routine urinalysis), vital signs, electrocardiograms (ECGs), and physical examinations until the 72 h follow-up contact. All relevant information regarding the AE/SAE was recorded using the appropriate data collection tool. The severity of AEs was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0).