Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis);Abnormal clinically significant changes in vital signs;Abnormal clinically significant physical examination;Number, percentage, and severity of solicited local and systemic reactogenicity AEs;Number, percentage, and severity of treatment-related AEs;Number, percentage, and severity of unsolicited AEs

Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis);Abnormal clinically significant changes in vital signs;Abnormal clinically significant physical examination;Number, percentage, and severity of solicited local and systemic reactogenicity AEs;Number, percentage, and severity of treatment-related AEs;Number, percentage, and severity of unsolicited AEs