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Preclinical studies (in vitro and in vivo animal models) consistently demonstrate its robust regenerative and cytoprotective properties

Status Not FDA-approved for any human use

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Use in Specific Populations (8.6).] When JANUVIA was used in combination with insulin or insulin secretagogues (e.g., sulfonylurea), medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin