Hofmann, Birte Maria http://orcid.org/0000-0001-8245-2630
Ahola, Manja
Fels, Lueder M.
Klein, Stefan
Lindenthal, Bernhard
Pihlaja, Jyrki
Funding for this research was provided by:
Bayer
Article History
Accepted: 12 December 2022
First Online: 17 January 2023
Declarations
:
: The original phase II study was funded by Bayer AG, Berlin, Germany.
: Birte Maria Hofmann, Lueder M. Fels, Stefan Klein and Bernhard Lindenthal are employees of Bayer AG, Berlin. Germany. Manja Ahola and Jyrki Pihlaja are employees of Bayer OY, Turku, Finland.
: The original phase II study was registered at https://clinicaltrials.gov/ct2/show/NCT03562624, clinical trial registration number NCT03562624. Approvals were obtained from the Institutional Review Boards and Independent Ethics Committees for each participating center and the study was conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines.
: All participants provided written, informed consent prior to study start.
: Not applicable.
: Not applicable.
: Upon request from qualified scientific and medical researchers, Bayer (the study sponsor) will share patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials, as necessary for conducting legitimate research. 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. 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.
: Birte M. Hofmann, Lueder Fels, Stefan Klein, and Bernhard Lindenthal participated in the development of the study design, and analysis and critical discussion of data. Manja Ahola and Jyrki Pihlaja participated in the conduct of the in vitro characterization analyses and critical interpretation of data outputs. Michal Zvolanek participated in critical discussion of data. All authors contributed to the initial manuscript draft and critically appraised all subsequent drafts. All authors read and approved the final manuscript.