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Adverse events were predominantly gastrointestinal and included nausea (2.2%30.5%), diarrhea (2.2%12.5%), constipation (2.9%25%), and abdominal pain (1.1%14.6%), with frequencies comparable to those reported in non-IBD populations

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They are unapproved compounded products, prepared by compounding pharmacies, which have not been reviewed by the FDA for safety, efficacy or quality in this indication