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Ethical approval was obtained from the Ethics Committee for Multicentre Clinical Trials\/Bulgarian Drug Agency (Bulgaria), the Ethik-Kommission der \u00c4rztekammer Nordrhein\/Paul-Ehrlich-Institut\u2014Bundesamt f\u00fcr Sera und Impfstoffe (Germany), the Bioethics Committee-Romanian College of Physicians (Bucharest, Timisiora, Cara-Severin, Cluj), National Medicines and Medical Devices Agency (Romania), and the Multicenter Ethics Committee Hospital Brno\/State\/Institute for Drug Control and the Ethics Committee Hospital Hradec Kr\u00e1lov\u00e9\/State\/Institute for Drug Control (Czech Republic). Written informed consent was obtained from all patients involved in this trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Statement"}},{"value":"Achim Rose and Herbert R\u00fcbben are Consultants for Innovacell Biotechnology AG.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}}]}}