Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); including nasal cavity examination findings; physical examination findings; abnormal clinically significant vital signs (body temperature; heart rate; respiratory rate; blood pressure); 12-lead electrocardiograms (ECGs) and laboratory parameters (hematology; coagulation; chemistry and urinalysis/urine microscopy)[Day 1; Day 7; Day 15 and Day 21 (telephone follow-up only) post first dose]

Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); including nasal cavity examination findings; physical examination findings; abnormal clinically significant vital signs (body temperature; heart rate; respiratory rate; blood pressure); 12-lead electrocardiograms (ECGs) and laboratory parameters (hematology; coagulation; chemistry and urinalysis/urine microscopy)[Day 1; Day 7; Day 15 and Day 21 (telephone follow-up only) post first dose]