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Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes

Published protocols also note pregnancy, known hypersensitivity to IGF-1 analogs, and pre-existing insulin resistance or diabetes as conditions requiring exclusion or enhanced monitoring in study design

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