The drugged patients are 'very mild dementia' on the CDR-SB scale, placing them somewhere in AD stages 2 to 3, in which case your second paragraph taken from the FDA guidance would be the operating one (if based on Sum of Boxes). And we do appear to meet the "positive trends on functional outcome assessments" with ADL.
The bigger issue with our TEAEs is the impact it had on our already low n. The regulators will have to get comfortable with not just the eye-raising number of dropouts but the number of completed participants and the limited endpoint data sets.
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