The safety evaluation included assessment of adverse events (AEs), clinical laboratory parameters, vital signs, and ECGs. Blood and urine samples for clinical laboratory parameters (hematology, clinical chemistry, coagulation, and urinalysis) were collected in the fasting state, at screening, prior to study drug administration on days 0, 12, 13, 14, and 15, prior to breakfast on day 16, and at follow-up. Vital signs and ECGs were recorded after 15 min of supine rest at screening, prior to and 5.5 h after study drug administration on days 0, 12 (ECG recorded pre-dose only), 13, 14, and 15, prior to breakfast on day 16, and at follow-up. The hemodynamic profile was also a measure of safety.