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It is unclear whether HHcy is a consequence of MTHFR polymorphisms [154], as it can also be associated with hypertension, folate deficiency, drug use, impaired renal function, alcoholism, and smoking [153]

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10.1038/emboj.2013.228 34 CaligioreD.PezzuloG.BaldassarreG.BostanA

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As of now, there has been no formal FDA rule broadly removing a defined group of peptides from Category 2