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In male rats (n = 65 per sex per dose group), incidences of hibernoma (tumor of the brown fat) were increased at the mid dose (1 tumor, 5 mg/kg/day, 23 times the MRHD exposure based on AUC) and maximum dose (2 tumors, 15 mg/kg/day, 67 times the MRHD exposure based on AUC)

On the contrary, wine no longer aroused astonishment, as it had been around for thousands of years and was produced in many European countries, well-rooted in local customs and cultures

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