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This is the first Phase 3 study. FDA for traditional approval was completed last quarter with regulatory action expected by the end 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. Approximately half of participants met this threshold at 12 months and approximately seven of every ten participants reached it at 18 months.

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