Acknowledgements
The authors would like to thank all of the patients who participated in this study and their families, as well as all the investigators and site staff who made the study possible. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Rhian Dyer MSc and Clair Clowes MPhil, of Ashfield MedComms, an Inizio Company, funded by Takeda Pharmaceutical USA, Inc., and complied with the Good Publication Practice-3 (GPP3) guidelines (Battisti WP, et al. Ann Intern Med 2015;163:461–4).