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11.Helmut Wakeham to Hugh Cullman, The Question of Deleterious Substances in DAP-BL, Philip Morris, June 23, 1962, Bates no

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Both IRB boards waived the need for consent to participate and determined that this secondary research study of deidentified survey data does not meet the federal regulation definition of research with human subjects according to 45 CFR 46.102(e) [1]