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Methods: The study population includes two prospective cohorts of ischemic stroke and TIA patients, the STROKE-CARD Registry (NCT04582825) and the STROKE-CARD trial (NCT02156778) with its long-term follow up study (NCT04205006)

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Since B12 is found primarily in animal products, including meat, fish, dairy, and eggs, a substantial reduction in food intake can reduce B12 consumption below optimal levels, particularly for patients who were already borderline deficient before starting treatment or whose diets lean toward plant-based foods

Its inclusion in the Category 2 restricted list has drawn criticism from clinicians who point to its legitimate international approval record as evidence that the safety concerns cited by the FDA are inconsistent with the global clinical literature

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