Safety and tolerability endpoints • The following safety variables will be recorded at regular intervals during the study: • Nature, frequency, duration, severity, and causality of adverse events (AEs) and serious adverse events (SAEs) • Clinical laboratory, tests (hematology, clinical chemistry and urinalysis) • Vital signs (supine blood pressure [BP], pulse rate, oxygen saturation (SpO2), body temperature and respiratory rate [RR]) • Standard 12-lead Electrocardiogram (ECG) • Concomitant medication assessments • Physical examinations • Local tolerance

Safety and tolerability endpoints • The following safety variables will be recorded at regular intervals during the study: • Nature, frequency, duration, severity, and causality of adverse events (AEs) and serious adverse events (SAEs) • Clinical laboratory, tests (hematology, clinical chemistry and urinalysis) • Vital signs (supine blood pressure [BP], pulse rate, oxygen saturation (SpO2), body temperature and respiratory rate [RR]) • Standard 12-lead Electrocardiogram (ECG) • Concomitant medication assessments • Physical examinations • Local tolerance