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However, because Leqembi is subject to the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease under coverage with evidence development (CED), [241] and because Leqembi was initially marketed and sold under accelerated approval, Leqembi coverage under Part B required the product to be furnished in a randomized controlled trial (RCT) conducted under an investigational new drug (IND) application
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