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As noted in the introduction, the course of events in cell cultures may be accelerated because of incubation in room air with a higher pO 2 than that in the hepatic lobule

Abbreviations AE: Adverse event AKI: Acute kidney injury BARDA: Biological Advanced Research and Development Authority CDC : Centers for Disease Control and Prevention CPB: Cardiopulmonary bypass CRO : Clinical research organization CVS: Cardiovascular surgery DAT: Direct antiglobulin test DSMB: Data and Safety Monitoring Board EDC : Electronic data capture eCRF: Electronic case report forms EDQM : European Directorate for the Quality of Medicines & Healthcare FDA: Food and Drug Administration GCP: Good Clinical Practice GSH: Glutathione HLA: Human leukocyte antigen IAT: Indirect antiglobulin test IRB: Institutional review board IWRS : Interactive Web Response System mITT: Modified intention-to-treat NHSN: National Healthcare Safety Network PPS: Per-protocol set PRT: Pathogen reduction technology RBC: Red blood cell S-303: Amustaline SAE: Serious adverse event SCD : Sickle cell disease sCr: Serum creatinine SROS: Study red blood cells only set RRT : Renal replacement therapy TTI: Transfusion-transmitted infection TA-GVHD: Transfusion-associated graft-versus-host disease TEAE: Transfusion emergent adverse event TR: Transfusion reaction TRALI: Transfusion-related acute lung injury References Godbey EA, Thibodeaux SR

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