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FDA will not review the DMF content until they review the content of the generic drug application

There are many key factors to understand when balancing methylation, the interaction of B12 and understanding how other body systems interact with these pathways

That makes careful monitoring and risk stratification the sensible approach rather than blanket avoidance for most patients, while high-risk individuals get closer follow-up

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[Abstract]2022 Dec;60(1):958-967

Clinical trials show that some patients experience mild to moderate blood pressure reduction, though severe hypotension remains uncommon when treatment is properly monitored