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Response: Regarding commenters' requests for exclusion criteria, we note that the measure methodology, including consideration of potential exclusions, was informed by extensive literature review, empiric analyses, and feedback from the TEP, PFE Work Group, and the public comment period held during measure development

The FDA is involved at many levels and is undergirded by a large pool of volunteers that is in the millions allowing for more rapid recruitment and trial completion

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Methods Animal surgery and post-surgery procedures All animal studies were conducted in compliance with EU directives for animal experimentation and were approved by the Ethical Committee of Paris North and The French Minister of Higher Education, Research and Innovation (MESRI APAFIS #8290)