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Author Contributions: AMR and AMS made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; have been involved in drafting the manuscript and revising it critically for important intellectual content; and have provided final approval of the version to be published. ZL and MM made substantial contributions to conception and design or interpretation of data; have been involved in revising the manuscript critically for important intellectual content; and have provided final approval of the version to be published. DWD, MDF, JN, and JWW made substantial contributions to interpretation of data; have been involved in revising the manuscript critically for important intellectual content; and have provided final approval of the version to be published. JP provided supervision/mentorship on the study; has been involved in revising the manuscript critically for important intellectual content and gave final approval of the version to be published.
Declaration of Conflicting Interests: The study sponsor was involved in the design of the study, interpretation of the data, and preparation, review, and approval of the manuscript. AMR and AMS are employed by Evidera, which provides consulting and other research services to pharmaceutical, device, government, and non-government organizations. As Evidera employees, they work with a variety of companies and organizations and are expressly prohibited from receiving any payment or honoraria directly from these organizations for services rendered. ZL, JP, and MM are employees of Novartis. DWD receives research support from Eli Lilly. JWW is currently a consultant for Pfizer, Lundbeck, Cyberonics, Eisai, Sunovion, Supernus, and Upsher-Smith; he is part of a speaker's bureau for Lundbeck, Questcor, Cyberonics, Eisai, and Supernus. He has received research grants from the National Institutes of Health, Shainberg Foundation, GSK, Cyberonics, Eisai, Upsher-Smith, and Novartis. JN is employed by the Tuberous Sclerosis Alliance.
Funding: Funding for this study was provided by Novartis Oncology.
Ethical approval: Institutional review board approval was granted by Ethical & Independent Review Services, Independence, MO.