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An institutional review board (IRB) in the USA (Pearl IRB) considered this study to be exempt according to FDA 21 CFR 56.104 and 45CFR46.104(b)(2):(2)
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[DOI] [PMC free article] [PubMed] [Google Scholar] 47.Bailey S.M., Lewis A.D., Knox R.J., Patterson L.H., Fisher G.R., Workman P
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