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It is the FDAs way of flagging a substance that may present significant safety risks when used in compounding

1 H MRS in the muscle allows detection of multiple metabolites, of which creatine, acetyl-carnitine, carnosine and intramyocellular lipids (IMCL) have been shown to be useful biomarkers of muscle metabolism [23]

11 , e201700377 (2018)

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(PubMed) Perkins AJ, Hendrie HC, Callahan CM, et al

G., Madala, H