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Article History

Received: 22 June 2020

Accepted: 23 July 2020

First Online: 17 August 2020

Ethics approval and consent to participate

: The ANNOTeM study has been approved by the ethics committee (Charité Campus Mitte; Berlin/Germany; no. EA1/078/10 and subsequently by the responsible ethics committees in Brandenburg (AS 90(bB)/2018) and Mecklenburg-Western Pomerania (BB 057/18)) and the Data Protection Department of the Charité. Any changes to the study protocol, must be approved by the Ethics Committee before implementation. According to the positive votes of the ethics committees, informed consent for participation in this study is not necessary.Within ANNOTeM, the analysis of outcomes is carried out on the basis of health insurance data. A formal approval of the participating hospitals or individual patients for using data of the health insurances is not necessary. The evaluation of the data is based exclusively on anonymised data, which are therefore no longer subject to the General Data Protection Rights (GDPR). The release of the data of the health insurance companies for this purpose was approved by the supervisory authority of the health insurance companies. It is registered at German Clinical Trials Register (DRKS00013067, date of registration: November 16th, 2017, URL: ). The study will be conducted in accordance with the Declaration of Helsinki in its current version, the guidelines of the International Conference on Harmonization of Good Clinical Practice (ICH-GCP), and the applicable German laws.

: AA, KB, HE, SE, CG, FIK, SK, KK, IS, ST, and JEW report no disclosures.ME reports grants from Bayer and fees paid to the Charite from Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daichi Sankyo, Novartis, Pfizer, Sanofi, all outside of this work.AF has received consulting fees from Bayer, Roche, Novartis, Biogen Idec, and NovagoTherapeutics, and honoraria for oral presentations from Novartis, Böhringer-Ingelheim, Eli-Lilly and Company, Biogen Idec, Paul-Martini-Stiftung, and Daiichi-Sankyo.TK reports having contributed to an advisory board of CoLucid and a research project funded by Amgen, for which the Charité – Universitätsmedizin Berlin received an unrestricted compensation. He further reports having received honoraria from Lilly, Newsenselab, and Total for providing methodological advice, from Novartis and from Daiichi Sankyo for providing a lecture on neuroepidemiology and research methods, and from the BMJ for editorial services. HJA reports speaker fees and consultancy honoraria received during the conduct of the study from Bayer Vital, Boehringer Ingelheim Pharma, Bristol-Myers-Squibb, Novo Nordisk and Pfizer.