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. 2017 May 27;102(6):961–969. doi: 10.1002/cpt.711

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© 2017, The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Serum levels of liver safety biomarkers (a) microRNA‐122 (miR‐122), (b) glutamate dehydrogenase (GLDH), (c) caspase‐cleaved fragment of K18 (cc‐K18), (d) full length keratin‐18 (FL‐K18), and (e) macrophage colony stimulating factor (CSF‐1). Serum samples were collected at four different timepoints relative to cimaglermin alfa (or placebo) administration from 12 patients who participated in phase I clinical trials including two patients which met FDA drug‐induced liver injury (DILI) guidance stopping criteria (Subjects 8 and 12), as well as others with elevated serum aminotransferases that fell short of meeting FDA DILI guidance stopping criteria (Subjects 1, 2, 3, 4, 7, 9, 10, 11), and two placebo‐dosed individuals (Subjects 5 and 6).