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The FDA isn't required to follow advisory committee recommendations but typically does

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The report was uncontrolled, unblinded, not randomized, had no comparator arm, used patient-reported outcomes rather than validated pain instruments, and did not publish dose, effect size, confidence intervals, p-values, or systematically collected adverse events limitations that severely constrain any clinical inference

Nat Rev Gastroenterol Hepatol 15(7):397411

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