Document is current

Article History

Received: 23 August 2020

Accepted: 27 October 2020

First Online: 26 November 2020

Ethics approval and consent to participate

: The study was conducted in accordance with the International Conference on Harmonisation for Good Clinical Practice. Local ethics committees approved the study (AUS: Melbourne Health Human Research Ethics Committee, Parkville VIC; Bellberry Limited, Eastwood SA; Uniting Care Health, Eastwood SA; NZ: Central Health and Disability Ethics Committee, Thorndon, Wellington; US: Copernicus Group IRB, Cary NC; Columbia University IRB, New York NY; Mayo Clinic IRB, Rochester MN and The University of Chicago IRB, Chicago IL) See Additional file: Table S9 for additional details. Written, informed consent was obtained from each patient included in the study.

: Not applicable

: GG, KEG, HLH, KMN, KET, LJW and RPA were former employees of ImmusanT, Inc. JAT-D and AJMD served as advisors to ImmusanT, Inc. RPA is the inventor of patents, owned or licenced by ImmusanT, Inc., relating to the diagnostic application of gluten challenge.