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The individual components (methionine, inositol, choline, cyanocobalamin) are FDA-recognized substances, but the combined formulation is not an FDA-approved drug product

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1,2 Type I (immediate) hypersensitivity reactions occur when IgE binds and cross-links to a specific antigenic determinant

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The abundance of TGF1 in EV39 suggests its role in mediating the enrichment of TGF1 signaling pathways by EV39