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Article History

Accepted: 23 April 2025

First Online: 16 May 2025

Declarations

:

: This work was supported by the NASPGHAN Foundation George Ferry Young Investigator Award and K23 DK115827 awarded to V.S. D.G. received salary support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5R01HD096435, R01HD102949, R01HD113201, and HHSN275201000003I). T.D. was supported by the National Institute of General Medical Sciences of the National Institutes of Health under award no. T32GM086330. K.K. received salary support from the National Center for Advancing Translational Sciences (NCATS KL2TR002367). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. V.E.H. was supported through a UNC/GlaxoSmithKline (GSK) Pharmacokinetics/Pharmacodynamics Post-Doctoral Fellowship.

: V.S. is a full-time employee of Ironwood Pharmaceuticals and may hold stock; this current affiliation has no financial or scientific bearing on the content of this manuscript. D.G. is an editorial board member of Clinical Pharmacokinetics. D.G. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The remaining authors have no relevant competing interests to report.

: The data that support the findings of this study are available from the corresponding author upon reasonable request. Some data may not be made available because of privacy or ethical restrictions.

: The study protocol was approved by the Children’s Mercy Kansas City Institutional Review Board including ethical considerations (IRB no. Study00000201; approval date 7/7/2018), and the study was conducted in accordance with the principles of the Declaration of Helsinki.

: All participants and their parents or legally authorized representatives (caregivers) provided informed consent and assent for study participation and publication.

: Not applicable.

: V.S. and V.W. were responsible for the conception and design of the clinical study. V.S., V.W., J.R., R.S., A.S., S.C., and N.A. performed the data acquisition. V.E.H., D.G., K.E.K., T.C.D., N.A., S.C., V.W., J.R., and V.S. performed the analysis and interpretation of data. V.E.H., D.G., K.E.K., and V.S. wrote the manuscript. All authors read, edited, and approved the final version of this manuscript.

: NONMEM control stream code for the final model is available as Electronic Supplementary Material.