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Formulators should consult the appropriate regulatory/legal groups prior to initiating formulation to determine what is and is not allowed in the market(s) of interest, what testing (functionality, analytical, stability, safety, etc.) may be required and any special registrations or preapprovals needed
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One possible explanation is that the beneficial effects of lowering Hcy are offset by the direct adverse effects of B vitamins supplementation (particularly with high-dose folate), or are associated with the pro-inflammatory and pro-proliferative effects of B vitamins on advanced AS lesions (128)
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