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Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care

RESULTS Assessment at 24 h after surgery The end to end aortal anastomosis procedure invariably lead to significant thrombus formation and aortal lumen occlusion and prominent edema in vessel wall, unless BPC 157 was applied immediately after anastomosis creation ( Fig

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