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Approximately half of participants met this threshold at 12 months and approximately seven of every ten participants reached it at 18 months. Submissions to other global regulators are currently underway, and the majority will be consistent with study findings to date, that donanemab met the primary and all cognitive and functional secondary endpoints in the Journal of the brain (ARIA-E) or as microhemorrhages or superficial siderosis (ARIA-H), in either case detected by MRI, and these may be serious and even fatal in some cases. Submissions to other global regulators are currently underway, and the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

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