Acknowledgements
The authors thank the study participants and their families, and the staff at all study centers. Research was sponsored by Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, USA. The authors acknowledge Marcel Kuttab, PharmD, and LaVerne Mooney, DrPH, of Takeda Development Center Americas, Inc. (TDCA), for editorial assistance. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Helen Wilkinson, PhD, of Ashfield MedComms, an Inizio Company, funded by Takeda Pharmaceuticals, USA, and complied with the Good Publication Practice-3 (GPP3) guidelines (Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. 