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Without pharmaceutical-grade manufacturing standards, independent batch testing, and validated stability data, there is no reliable way for an individual to confirm the potency, purity, or safety of any such product

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The clinical trial averages represent population-level expectations rather than individual guarantees

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Measure hematologic parameters on an annual basis and vitamin B12 measurements at 2- to 3-year intervals in patients on JANUMET XR and manage any abnormalities [see Adverse Reactions (6.1)]