3.1.3. Safety Analysis
Safety was evaluated by AEs, vital signs, and laboratory assessments of patients. AEs and SAEs were reported in the placebo group of 119 patients (58.26% and 0), IVIB 400 mg group of 115 patients (60.36% and 1.74%), and IVIB 800 mg group of 111 patients (68.91% and 2.70%), respectively, and there were no differences between groups (