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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
Patients on thyroid hormone replacement should be aware that increased lipolysis can transiently shift free fatty acid levels, which may alter thyroid hormone binding in vitro, though this is unlikely to be clinically significant [4]
maintains a registry to monitor the pregnancy outcomes of women exposed to Januvia while pregnant
