Funding for this research was provided by:
Received: 22 July 2020
Accepted: 3 September 2020
First Online: 18 September 2020
: This study was sponsored by Bayer SA/NV. Bayer SA/NV also funded the journal’s Rapid Service Fees.
: Medical writing support was provided by Sarah Feeny (ApotheCom, London, UK) and was funded by Bayer Consumer Care AG, Pharmaceuticals, Switzerland.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: Joke Ruys: Novartis, Bayer (consultant); Werner Dirven: Novartis, Bayer, Allergan (consultant); Els Mangelschots: Bayer (consultant); Julie Jacob: Novartis, Bayer, Zeiss (consultant), Thea Pharma (research grant); Filip Mergaerts: Novartis, Bayer (symposia); Alexandra Kozyreff: Bayer, Novartis, Allergan, Abbvie, Mylan (consultant).
: Approvals from independent ethics committees were obtained for all participating centres prior to study start (Electronic Supplementary Material Table).
: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patients-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after 1 January 2014.Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsors section of the portal. Data access will be granted to anonymized patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded. In this study, data were collected in an aggregated manner per centre.