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Lantos JD, Wendler D, Septimus E, Wahba S, Madigan R, Bliss G. Considerations in the evaluation and determination of minimal risk in pragmatic Clinical Trials. Clin Trials. 2015 Oct;12(5):485-93. doi: 10.1177/1740774515597687. Epub 2015 Sep 15. PubMed PMID: 26374686; PubMed Central PMCID: PMC4703320.

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