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However, he added that since many of these experimental peptides dont have the same robust catalog of clinical trial data as FDA-approved medications, evaluating them for the 503A Bulks List may prove challenging for the committee and the agency

Nutritional folate deficiency combined more or less with the C677T MTHFR mutation may play an important role in basal hyperhomocysteinemia, whereas vitamin B 6 deficiency and heterozygosity for a CBS defect may only contribute to abnormal increment of postmethionine-load homocysteine levels (Ubbink et al, 1996)

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