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Yao W, Hadi T, Jiang Y, Lotz J, Wronski TJ, Lane NE

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87 Autopsy findings in CMS patients show widespread pathological changes 68 : (1) Heart: enlarged volume/weight with dilated chambers filled with clots, myocyte necrosis, and endothelial swelling in myocardial capillaries

FDA can consider the committees votes, the discussion, the staff analysis, and public comments as it determines the next regulatory step