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(now Sumitomo Dainippon Pharma Oncology, Inc.) and has consulted for AstraZeneca, Bristol-Myers Squibb, Novartis, and Takeda. ARH reports consulting or an advisory role for Merck, GlaxoSmithKline, Bristol-Myers Squibb, and Eisai, and research funding (paid to institution) from Karyopharm Therapeutics, Merck, Bristol-Meyers Squibb, GlaxoSmithKline, Roche\/Genentech, Janssen, AstraZeneca\/Medimmune, Astellas Pharma, Macrogenics, and Boehringer Ingelheim.. WAH has nothing to disclose. KKC is an employee of Syneos Health. EK-Y is an employee of Sumitomo Dainippon Pharma Co., Ltd (parent company of Sumitomo Dainippon Pharma Oncology, Inc.). MO and ZL are employees of Sumitomo Dainippon Pharma Oncology, Inc. BE is a former employee of Boston Biomedical, Inc (now Sumitomo Dainippon Pharma Oncology, Inc.). WLS received research support from Boston Biomedical, Inc. (now Sumitomo Dainippon Pharma Oncology, Inc.), Eli Lily and Company, and Lexicon Pharmaceuticals; and honoraria for consultation from Blueprint Medicines, Ipsen, Lexicon Pharmaceuticals, Mylan, and Natera, Inc.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was conducted in compliance with the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, and applicable national and local regulatory requirements. The study protocol was approved by the Independent Ethics Committee or Institutional Review Board at each participating site: the University Health Network Research Ethics Board (FWA00000518); Emory University Institutional Review Board (FWA00005792_IRB00082294); Western Institutional Review Board (IRB00000533_IORG0000432); Yale University Human Subjects Committee (FWA00002571); Cleveland Clinic Institutional Review Board (FWA00005367); USOncology Inc. Institutional Review Board (IORG0000759).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent prior to study participation.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets used and\/or analyzed during the current study are available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"AS, ARH, WAH, KKC, and WLS treated patients and performed the clinical data acquisition. ZL provided statistical data analysis and KKC, EK-Y, MO, and BE interpreted the data. All authors contributed to writing and critically revising the manuscript for important intellectual content and approved the final draft. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}