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S\u0142awomir Jeka: None declared. Eva Dokoupilov\u00e1: Research grants from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Sanofi-Aventis and Hexal AG. Jan Brandt-J\u00fcrgens: None declared. Juan Manuel Miranda Lim\u00f3n: None declared. Miguel Cantalejo Moreira: None declared. Raul Veiga Cabello: None declared. Julia Jauch-Lembach: Employee of Sandoz. Anjali Thakur: Employee of Sandoz. Halimuniyazi Haliduola: Employee of Sandoz. Ines Brueckmann: Employee of Sandoz. Norman B. Gaylis: None declared.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted in accordance with the ethical principles derived from the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practices and in compliance with local regulatory requirements. The study protocols were approved by the Independent Ethics Committee or Institutional Review Board for each center.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent before entering the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All patients provided their consent for their data to be published.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All data generated or analyzed are included in this article and the supplementary information files. Anonymized datasets and related documents such as the statistical analysis plan, protocol and amendments can be shared upon reasonable request through a data sharing agreement.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Julia Jauch-Lembach and Halimuniyazi Haliduola contributed to the design of the study; Piotr Wiland, S\u0142awomir Jeka, Eva Dokoupilov\u00e1, Jan Brandt-J\u00fcrgens, Juan Manuel Miranda Lim\u00f3n, Miguel Cantalejo Moreira, Raul Veiga Cabello and Norman B. Gaylis contributed to the conduct of the clinical study; Halimuniyazi Haliduola, Julia Jauch-Lembach, Anjali Thakur and Ines Brueckmann contributed to the analysis and interpretation of the results. All authors discussed the results and contributed to the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}