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Although the studys primary endpoint, which focused on changes in the glucose metabolism in the brain, was not met, the secondary endpoint of changes in scores for clinical and cognitive measures, as well as the exploratory endpoint of brain volume, showed a statistically significant improvement

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The use of claim 28 wherein the PDE-5 inhibitor is employed for manufacture of a medicament for treatment by oral administration

TRIUMPH-1 discontinuation rates were 4.1%, 6.9%, and 11.3% on the 4 mg, 9 mg, and 12 mg arms

She experienced gastroparesis that caused severe vomiting, which led to her teeth falling out

Ricciotti and FitzGerald 2011)