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Article History

Received: 13 November 2019

Accepted: 18 June 2020

First Online: 16 July 2020

Ethics approval and consent to participate

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.Written informed consent was obtained from all individual participants prior to completing any study measures or procedures.

: Not applicable.

: RMS and HLG are are employed by Evidera, which provides consulting and other research services to pharmaceutical, medical device, and related organizations. In their salaried positions, they work with a variety of companies and organizations, and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received funding from Daiichi Sankyo to perform the study and develop this manuscript. XY is an employee of Daiichi Sankyo Inc. which provided funding for this study. NMB has and may receive honoraria for serving as a consultant.All authors listed meet the requirements for authorship, believe that this manuscript adheres to ICMJE requirements, and have read and approved this final version of the manuscript and the authorship list.