Safety assessments
ADVERSE EVENT
Safety was monitored through physical examination (symptom-driven), vital signs measurements, electrocardiograms, and clinical laboratory tests (serum chemistry, hematology, and urinalysis). Adverse event (AE) information was also collected throughout the study. AEs [including serious AEs (SAEs)] were recorded from the start of the first product used until the end-of-study telephone call. Severity/intensity were graded as mild, moderate, or severe, and AEs were also assessed as unlikely, possibly, or probably related to the study product by the investigator.
