Funding for this research was provided by:
Efficacy and Mechanism Evaluation Programme (15/74/01)
Received: 8 March 2019
Accepted: 8 July 2019
First Online: 20 August 2019
Ethics approval and consent to participate
: Informed consent will be obtained from participants prior to entry into the trial. The trial has been submitted to and approved by Yorkshire & The Humber – Leeds West Research Ethics Committee (ref 17/YH/0262), the Medicines & Healthcare products Regulatory Agency (EudraCT: 2017–000533-31), the Health Research Authority (HRA) (IRAS project ID 219133) and local R&D departments for each participating site prior to entering patients into the trial.
: No data on individual persons are used in the manuscript.
: RS has received research funding from Lesaffre and Ironwood. He has also acted on advisory boards for Allergan, Commonwealth Diagnostics International, Danone, Ipsen, and Yuhan, and received speakers’ fees from Menarini. MS has received speakers’ fees and honoraria from Medical Measurement Systems (MMS)/Laborie.