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The FDA also recommends examining hard clinical endpoints such hepatic decompensations, transplant free survival, and all-cause mortality, although these results are not necessarily needed prior to drug approval given the long length of follow up potentially required

Progress will depend on biomarker-driven, biologically enriched trial designs capable of determining whether the pleiotropic benefits observed in experimental systems translate into meaningful disease modification

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I., Sanz-Soler, R., Johanningmeier, B

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