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.