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FDA objected to claims implying the compounded product performs like the FDA-approved version based on clinical proof

however, medical professionals are able to distinguish the following most frequently reported effects

In the years immediately following the IOMs 1998 report setting the current RDA, research associated an abnormally high level of homocysteine, a molecule involved in protein metabolism, with an increased risk of cardiovascular disease, mortality, and cognitive impairment

Voet D, Voet J