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Article History

First Online: 30 July 2020

Compliance with Ethical Standards

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: All authors were involved in acquisition, analysis, or interpretation of data for the work. MV is the principal investigator of EMPIRE. All authors were involved in drafting the work or critically revising it for important intellectual content, and provided final approval of the version to be published.

: This study was supported by Boehringer Ingelheim International GmbH (BI). Medical writing assistance was provided by Islay Steele, PhD, of Nucleus Global, which was contracted and funded by Boehringer Ingelheim International GmbH. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

: JK has received financial support, including consultant fees, support for travel to international conferences, lectures, honoraria, and clinical trials investigator payments from Boehringer Ingelheim and Roche. MH has received lecture fees and consulting fees and served as an advisory board member for Boehringer Ingelheim. VM has received consulting fees from Roche and Boehringer Ingelheim. DJ has received consulting fees or honorarium and payment for lectures from Roche and Boehringer Ingelheim. JT-T has received payment for lectures from Roche and Boehringer Ingelheim and consulting fees from Boehringer Ingelheim. MV has received an independent grant from Roche and consultancy, lecture, and advisory board fees from Boehringer Ingelheim and Roche. MS has received consultation fees from Boehringer Ingelheim. AK-F, NM, SL, KH have no personal conflicts of interest that are directly relevant to the content of this article.

: The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors.

: The EMPIRE registry protocol was approved in each country by the respective ethical committee. Written informed consent was obtained from all individual patients, who were enrolled in accordance with the Helsinki Declaration.

: Data sharing is not applicable to this article as no datasets were analyzed during the current study.