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And in blood vessels that are already less flexible or have cholesterol plaques, reintroducing estrogen in the form of hormone replacement therapy can increase the force and speed of blood flow with each heartbeat, sometimes causing a plaque in a vessel to break off and raising the risk of serious problems like heart attack, stroke, or blood clots, says Chervenak

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Some Phase 3 trial sites are in Asia (REDEFINE 5, REDEFINE 6) but no regulatory approvals have been announced as of June 2026

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