2.8.6. Safety Analyses
hematologic, blood chemistry
PATHOLOGY
The safety analysis evaluated the type and incidence of AEs, their severity, and their association with test products. Additionally, clinical pathology tests (hematologic, blood chemistry, and urine tests), vital signs (pulse, blood pressure), physical measurements (weight), and electrocardiogram test results were summarized descriptively. All AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA).All statistical analyses were conducted using SAS (Version 9.4, SAS