Acknowledgements
We thank all the study participants and their families, investigators, and study teams. Medical writing support was provided by MedPro Clinical Research, and was funded by Ono Pharmaceutical Co., Ltd. and Bristol Myers Squibb. The authors also thank Minal Jaggar, PhD, Vidula Bhole, MD, MHSc, and Ivan D’Souza, MS, of MedPro Clinical Research for providing medical writing support for this manuscript.