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[17] However, no large-scale, controlled trials have evaluated the efficacy or safety of ALA for pregnant patients, and thus there is insufficient evidence to consider it definitively safe

The physician writes the prescription after a consultation, an FDA-registered compounding pharmacy prepares the formulation, and the patient receives clear guidance on application protocol and realistic expectations

High homocysteine levels are also associated with neural tube defects, placental abruption, pre-term birth, and recurrent pregnancy loss.[ref] How is high homocysteine defined

Science 300(5619):644647