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Additionally, a 5 mol/L elevation in plasma Hcy was associated with a 1.61.8 times increased relative risk of coronary heart disease [47]

What it does mean is that the warning language that drove millions of women away from a potentially beneficial treatment for over two decades has now been formally revised - following the FDA's own comprehensive review of the evidence that supported the November 2025 announcement

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This problem should be further analyzed at a product level

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