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A randomized, double-blind, placebo-controlled study demonstrated that ROSE-010 was well tolerated and provided rapid and effective relief of acute pain attacks in IBS patients [60]

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The Committees vote is advisory, FDA will make the ultimate determination, and many of the most important questions remain unresolvedincluding how real-world evidence should be weighed, what quality standards should apply, and whether a guarded pathway can move existing use into a more regulated framework

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GHK-Cu works gradually, producing cumulative benefits over time