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Article History

Accepted: 17 March 2023

First Online: 27 April 2023

Declarations

:

: This work was supported by Bayer HealthCare.

: Steven C. R. Williams and Ndaba Mazibuko report research funding from Bayer, provided to the institution. Christian Zurth, Christian Kappeler, Iris Kuss, and Patricia E. Cole are employees of Bayer. Owen O’Daly and Fiona Patrick have no disclosures to declare.

: This study was conducted at a single study center in the UK (Center for Neuroimaging Sciences, Institute of Psychiatry, Psychology, and Neuroscience at King’s College Hospital, London). The protocol was reviewed and approved by the South Central—Berkshire Research Ethics Committee and the Medical and Healthcare Regulatory Authority before study initiation. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice, and met all local legal and regulatory requirements. All participants provided written informed consent.

: Written informed consent was obtained from all individual participants in the study.

: All authors reviewed and approved the manuscript submitted for publication and are responsible for the correctness of the statements provided in the manuscript.

: 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, timepoint and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (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 ExternalRef removed 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 member section of the portal. Data access to anonymized patient-level data, protocols and clinical study reports will be granted after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel, and will take all necessary measures to ensure that patient privacy is safeguarded.

: Not applicable.

: Conceptualization: SCRW, IK, PEC. Methodology: SCRW, OO’D, CZ, FP, CK, PEC. Formal analysis and investigation: SCRW, NM, OO’D, CZ, FP, PEC. Writing – original draft preparation: SCRW, OO’D, FP. Writing – review and editing: SCRW, NM, OO’D, CZ, FP, CK, IK, PEC. Funding acquisition: SCRW. Resources: SCRW. Supervision: SCRW, NM. All authors participated in the critical review and revision of this manuscript and provided approval of the manuscript for submission.