Funding for this research was provided by:
Received: 30 April 2020
Accepted: 2 November 2020
First Online: 13 November 2020
Ethics approval and consent to participate
: The clinical studies met all local legal and regulatory requirements and were conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) guideline E6: Good Clinical Practice (GCP). Analyses of psychometric and other measurement properties were conducted in line with scientific standards including the FDA PRO Guidance for Industry, 2009.
: Not applicable.
: CH, AF, CS, MB and CG are employees of Bayer AG. HD is an employee of Clinical Outcomes Solutions and formerly of ICON Patient Centered Outcomes. DW is an employee of Metronomia Clinical Research GmbH. Funding for this study was provided by Bayer AG and medical writing support was also funded by Bayer AG and provided by Afsaneh Khetrapal (Huntsworth Health).