2.8. Safety Outcome Measurements
ADVERSE EVENTS, BLOOD, ADVERSE REACTIONS, LIVER
The safety of the study was evaluated by monitoring the clinical conditions and adverse events of the participants, which were recorded on the case report form. Vital signs, electrocardiograms, and laboratory tests were conducted to assess safety. In addition to relying on the subjects’ reports, physicians proactively inquired about potential health issues at each patient visit to ensure the safety of participants. This approach allowed for a comprehensive recording of any adverse reactions. Additionally, systolic and diastolic blood pressure, pulse rate, vital signs, and a physical examination were undertaken to ensure the safety of the subjects. Further, hematological examinations were conducted to measure white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit, and platelet count. Blood biochemical tests were performed to measure bilirubin, alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), glucose, and creatinine levels. Liver and renal function tests were also conducted to evaluate safety. All the laboratory profiles of the subjects are shown in the 