Safety Outcome measurements
ADVERSE EVENTS, BLOOD
To evaluate safety, all adverse events (AEs) were monitored. Laboratory tests, urinalysis, vital signs, and electrocardiograms were performed before and after 16 weeks of administration. Laboratory tests included hematological tests [white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit, platelets] and blood bio-chemical tests [alkaline phosphatase (ALP), AST, ALT, total bilirubin, total protein, albumin, gamma-glutamyl transferase (gamma-GT), blood urea nitrogen (BUN), creatinine, glucose, lactate dehy-drogenase (LD), creatine kinase (CK), high sensitivity C-reactive protein (hs-CRP)]. Blood was collected after fasting for 12 h. Urinalysis measures specific gravity and pH in urine. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse were measured to evaluate vital signs.