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Temperatures were recorded non-invasively every 20 min starting 60 min before the first METH injection and continuing for 9 h thereafter using the DAS-5001 console system from Bio Medic

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Regular follow-up appointments, including blood tests, can track nutrient levels and detect potential adverse effects

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505(j)(2)(A)(viii), the generic does not need approval for a patented indication, and its label can omit that indication without triggering a Paragraph IV certification on the method-of-use patent

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