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Note that due to the relative small size of the rats, rat fistulas regularly appeared as large and complex, and thereby, in this respect, corresponded to the worst presentation in the patients (Klicek et al., 2008

These included reductions in functional and cardiovascular age, greater exercise tolerance, and notably lower mortality: treated individuals had 28% fewer deaths overall, about half the cardiovascular mortality, and reduced incidence of heart failure & respiratory disease compared to controls

Finally, it is unclear based on the data submitted by the applicant which prior procedures were performed

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