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Article History

Received: 14 November 2017

Accepted: 16 April 2018

First Online: 30 May 2018

Ethics approval and consent to participate

: Each investigator conducted the study according to the Declaration of Helsinki and the International Conference on Harmonisation’s Harmonised Tripartite Guideline for good clinical practices, and in compliance with applicable local or regional regulatory requirements. All patients enrolled in the study provided written informed consent in the manner deemed appropriate by the institutional review board or the independent ethics committees. For the full list of review boards and ethics committees providing approval, please see Additional file .

: LG is an employee of and owns stocks/stock options in Takeda Pharmaceuticals USA, Inc. MAB has received research grants from Ardea/AstraZeneca, Horizon, and Takeda and consultancy/other remuneration from Ardea/AstraZeneca, CymaBay, Horizon, Ironwood, and Takeda (total remuneration: Ardea/AstraZeneca, > $10,000; CymaBay, < $10,000; Horizon, < $10,000; Ironwood, < $10,000; and Takeda, > $10,000). AW is a consultant for Takeda (< $10,000). BH and MC are employees of Takeda Pharmaceuticals USA, Inc. KS has received research grants from Ardea/AstraZeneca, Horizon, SOBI and Takeda (> $10,000 from each company) and consultancy/other remuneration from Ardea/AstraZeneca (> $10,000), Horizon, Ironwood, SOBI, and Takeda (< $10,000 from each company).

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