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Taking Gabapentin could lead to weight gain as a potential outcome though it may not affect all individuals
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
13 Figure 24: CoEQ change from baseline at week 26, PIONEER 2 (FAS) CI = confidence interval
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