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Exceptions include public health concerns emerging that were unrecognized at the time of the protocol assessment, identification of a substantial scientific issue essential to the safety or efficacy testing that later comes to light, a sponsors failure to follow the protocol agreed upon, or the FDAs reliance on data, assumptions or information that are determined to be wrong

doi:10.1093/ajcn/86.3.718

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This study was designed to mimic sub-chronic intoxication with GLP in humans