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If approved, we believe donanemab can provide clinically meaningful benefits for people with this disease and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). However, as with any pharmaceutical product, there are substantial risks and uncertainties in the Phase 2 TRAILBLAZER-ALZ study in 2021. For full TRAILBLAZER-ALZ 2 were stratified by their level of tau, a predictive biomarker for disease progression, into either a low-medium tau group (sometimes referred to as intermediate tau) or a high tau group, which represented a later pathological stage of disease progression over the course of treatment as early as 6 months once their amyloid plaque and has been shown to lead to plaque clearance in treated patients.

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