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[24] If FDA had undertaken a thorough and effective review of all literature up to July 2009, as reported in their Final Rule, the Richardson, et al paper would have been identified

(2009) identified that all their subjects positive for amyloid-beta (via [11C]-PiB PET), measured in their frontal brain regions, posterior cingulate, as well as in superior parietal, lateral temporal and occipital lobe, had dementia (PDD and DLB) and a higher prevalence of APOE4 when compared to non-demented and demented subjects negative for [11C]-PiB (Maetzler et al., 2009)