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the FDA has stated it lacks sufficient information to know whether the substance would cause harm when administered to humans Evidence snapshot: The evidence base is almost entirely preclinical, decades of animal (largely rat) studies, mostly from one Croatian research group (Sikiric et al., University of Zagreb), with a single small human trial under the brand name "Bepecin" (around 2015) that did not lead to any FDA-approved use

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People with alcohol dependence or chronic illnesses Those taking certain medications that interfere with B12 absorption, including metformin and proton pump inhibitors