Safety Assessment
The safety of the drug was assessed by vital signs measurements, physical examination, laboratory tests, electrocardiograms, and adverse events. Adverse reactions were observed in all subjects during the trial. Coding was performed using MedDRA terminology, and categorical analysis was performed according to SOC/PT. A detailed list of adverse events, adverse reactions, and serious adverse events was tabulated by system and severity statistics of the number of cases and instances of adverse reactions.