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Article History

First Online: 14 August 2019

Compliance with Ethical Standards

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: This research was supported by Eli Lilly & Co, Madrid (Spain). JIM, TD, and JAS are employees of Eli Lilly & Co. MC and LL work for an independent research entity that received funding from Eli Lilly & Co to coordinate and conduct the study, and to write up the manuscript. JAJ, JARI, and JLI have nothing to disclose.

: This study was performed in accordance with the Helsinki Declaration of 1964, as revised in 2013, and was approved by the Clinical Research Ethics Committee of <i>Hospital Universitario 12 de Octubre</i> (Madrid). All study participants agreed to participate in the study and signed informed consent before enrollment.

: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.