An adverse event (AE) was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, not necessarily considered related to the study intervention. SAEs were defined as any AE which occurred at any dose and resulted in any of following outcomes: death, life-threatening experience (risk of death at the time of event), required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly. TEAEs are events between first dose of study drug up to maximum of 31 days after last dose of study drug.

Vital signs that were assessed included supine systolic blood pressure, diastolic blood pressure and supine pulse rate. Clinical significance was determined based on investigator's discretion.

ECG parameters that were assessed included PR interval, QRS interval, QT interval, QTCF (Fridericia's correction formula) and heart rate. Clinical significance was determined based on investigator's discretion.

Clinical laboratory tests included hematology, clinical chemistry and urinalysis parameters. Clinical significance of abnormalities in these parameters was determined based on investigator's discretion.

Draize score was used to measure the skin irritability based on erythema, edema, papules, and vesicles at the administration site. Draize score ranged from 0 to 4, where 0 indicated no reaction visible, 1 indicated trace reaction (barely perceptible pinkness), 2 indicated mild reaction (readily visible pinkness), 3 indicated moderate reaction (definite redness) and 4 indicated strong to severe reaction (very intense redness). In this outcome measure number of participants are reported according to their maximum score they had during the study through Day 1 to 11, regardless of visit and assessment location.