Safety assessment
erythema, swelling, pain
ADVERSE EVENTS, ERYTHEMA, INJECTION SITE REACTION
Safety assessments included adverse events (AE) monitoring, vital signs monitoring (systolic and diastolic blood pressure, pulse rate, oral body temperature and respiratory rate), physical examination, concomitant medication assessment, 12-lead electrocardiography and laboratory evaluations (clinical chemistry, hematology, coagulation and urinalysis). The injection site was assessed for erythema, pain, swelling and numerous other parameters according to a standardized local injection site reaction score every 1, 6, 12 and 24 h after injection. The safety of the subjects was assessed until discharge and during the end-of-study visit on day 12.