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Helmsley Charitable Trust (PM, LAD), and by the NIH grants R01DK132408 to PM, T32DK007727 to AN, T35DK060444 to AH, and P30DK078392 (Gene Analysis Core) of the Digestive Diseases Research Core Center in Cincinnati.","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AN, TM, KI, JRD, KJ, KL, AH, TA, BB, JH, and JN have no reported conflicts of interest. LAD is receiving research grant support from Takeda, and in-kind support from FrieslandCampina for a separate clinic trial. PM is receiving in-kind, drug-only support from Janssen Scientific Affairs, LLC for a separate clinical trial. KC and JY are employed by Esoterix, LabCorp specialty lab, Calabasas, CA.","order":2,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AN contributed with investigation, formal analysis, writing the original draft and editing. TM and KI performed data curation, investigation, and pharmacokinetic analyses. JRD contributed with conceptualization, methodology, formal analysis and edited the manuscript. KJ conducted the study design, data curation and edited the manuscript. KL conducted data curation, laboratory investigations and edited the manuscript. AH performed data curation and computational analysis. TA conducted endoscopic severity scoring and revised the manuscript. BB, JH, and JN were involved with study conceptualization, methodology, data curation and manuscript editing. LAD was involved in study conceptualization, methodology, and manuscript editing. PM contributed to the study concept and design, study methodology, obtained funding, performed statistical analysis and interpretation, drafted and revised the manuscript.","order":3,"name":"Ethics","label":"Author contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Once published, the de-identified dataset will be made available to researchers upon request to the corresponding author.","order":4,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was approved by the Institutional Review Board at all four participating centers, with the coordinating center located at Cincinnati Children\u2019s Hospital Medical Center (IRB# 2019-0730; approved 7\/23\/2019).","order":5,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All subjects or their guardians provided informed consent for this study before collecting any study data.","order":6,"name":"Ethics","label":"Informed consent","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"NONMEM code provided in Supplemental Materials.","order":7,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":8,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}}]}}