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[21] See FDAs online guidance on "Human Drug Compounding"

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Mechanistic sampling of intestinal tissue during this trial would best validate the reparative hypothesis if analyses include tight junction protein expression (e.g., claudins, occludin, zonula occludens-1), histologic healing assessments using validated indices (e.g., Geboes score, Robarts Histopathology Index), and intestinal permeability assays such as the lactulose-mannitol ratio

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