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Lewis RJ, Berry DA, Cryer H, Fost N, Krome R, Washington GR, Houghton J, Blue JW, Bechhofer R, Cook T, Fisher M. Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial. Ann Emerg Med. 2001 Oct;38(4):397–404. doi: 10.1067/mem.2001.118223. PMID: 11574796. |