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Three pilot studies with very small sample sizes, a Phase II trial whose results remain unpublished, and a regulatory record that reflects the FDA's own assessment that sufficient human safety data do not exist that is the complete ledger as of 2025

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When stratified by administration route, the average percentage reductions were: Intramuscular (IM): 48.3% Sublingual: 30.7% Oral: 30.3% These results suggest that IM administration leads the most pronounced homocysteine reduction, however, sublingual and oral routes also demonstrate clinically relevant effects

McGuire FP et al