Outcomes
ADVERSE EVENT, SECONDARY
The primary endpoint was the presence of Adverse Events (AEs), including and not limited to laboratory safety (biochemistry, hematology, and urinalysis); vital signs (supine systolic/diastolic blood pressure, pulse rate and body temperature); and 12-lead electrocardiogram (ECG: heart rate, PR interval, QRS duration, QT interval, QT interval corrected for heart rate using Bazett’s [QTcB interval] and Fridericia’s [QTcF interval] formulae). The secondary endpoints for this study were pharmacokinetics parameters: maximum concentration (C