Acknowledgements
The authors would like to thank all patients and their families, all investigators, Takeda and CROs of EP-CRUS (monitoring and research office), BI Medical (patient registration centre), BML (laboratory tests) and A2 Healthcare (statistical analysis) for their valuable involvement in this study. Medical writing assistance was provided by Reza Sayeed of MIMS Japan Co., Ltd. which was funded by Takeda Pharmaceutical Company Ltd. (Tokyo, Japan), and complied with Good Publication Practice 3 ethical guidelines (Battisti et al., Ann Intern Med. 2015;163:461–464).