Text and Data Mining valid from 2019-04-18
Received: 12 December 2018
Accepted: 26 March 2019
First Online: 18 April 2019
Ethics approval and consent to participate
: Institutional review boards or ethics committees at the participating investigational centres approved the study, which was conducted according to the principles set out in the Declaration of Helsinki, International Conference on Harmonisation Guidelines for Good Clinical Practice, and additional local regulations.
: Not applicable.
: Dr. Wagner was an employee of Takeda Pharmaceuticals International GmbH. Both Bernard Souberbielle and Didier Saurigny were employees of Takeda at the time of the study. Barbara Hunt is an employee of Takeda International, Deerfield, IL, USA. The other authors declare that they have no competing interests.
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