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[DOI] [PMC free article] [PubMed] [Google Scholar] 122.Coates MD, Tekin I, Vrana KE & Mawe GM Review article: the many potential roles of intestinal serotonin (5-hydroxytryptamine, 5-HT) signalling in inflammatory bowel disease

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Also similar to the previous blinded trial, a large proportion of the change in SFNSL score was attributable to questions that are relevant to autonomic symptoms

The guidance provides a framework for determining when selective safety data collection is appropriate, based on where an asset sits in development and the regulatory context around it