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While higher doses (particularly 54 mg) showed some increase in gastrointestinal-related events, these remained mild to moderate in severity and did not result in treatment discontinuation

Extracellular Vesicles Derived From Gut Microbiota, Especially Akkermansia Muciniphila, Protect the Progression of Dextran Sulfate Sodium-Induced Colitis

Sexton, Patrick M

Clin Ther 1995

Regulatory managers should make sure that the quality systems used by suppliers can handle both sending in the Drug Master File and being inspected by regulatory authorities

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