Safety monitoring

Safety was assessed by monitoring of AEs, SAEs, MACE, temperature log, physical examinations with vital signs and weight, cardiopulmonary examination, 12-lead electrocardiograms (ECGs), 24h Holter ECG monitoring (after the infusion was completed) and laboratory safety assessments (biochemistry, hematology, coagulations status, cardiac markers). An AE was defined as any untoward medical occurrence in a subject and could include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). A Clinical Endpoint Committee (CEC), blinded to randomized treatment assignments, was appointed to independently adjudicate investigator-reported MACE and other events of interest (supplemental materials). The study was monitored by an independent Data Safety Monitoring Board.