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the label also warns that rash, hives, or swelling of the face, mouth, lips, or tongue can signal a hypersensitivity reaction requiring emergency care, though no generalized allergic reactions were documented in the original trials Because current supply comes only from compounded preparations rather than an FDA-verified finished product, potency, purity, and sterility can vary by pharmacy, and unregulated online sources carry added contamination or mislabeling risk

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In addition, Baum et al

FDAAA 801, a US Federal law, includes a legal mandate for a study sponsor (or its designated PI) to register and report results for certain non-phase 1 interventional studies of FDA-regulated drugs or devices

exclusively for research purposes and is not approved for human consumption