Safety and Tolerability Analysis
Safety parameters were carefully monitored throughout the study. Clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, laboratory safety tests, and any other relevant safety variables were reported as adverse events (AEs), which were tabulated and summarized using MedDRA 23.1.
Results of vital signs, clinical laboratory variables, and ECG parameters [HR and the intervals: PR, QRS, QT, QT interval corrected with Bazett’s formula (QTcB), QT interval corrected with Fridericia’s formula (QTcF)], at each time point of measurement, were compared to baseline.
The safety analysis set (safety population) included all subjects who received at least one dose of the investigational product.