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Article History

Received: 24 May 2024

Accepted: 9 July 2024

First Online: 20 February 2025

Declarations

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: The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines and the World Medical Association Declaration of Helsinki 1964 and its amendments and subsequent clarifications. Ethical approval was obtained from the Ethics Committee for Multicentre Clinical Trials/Bulgarian Drug Agency (Bulgaria), the Ethik-Kommission der Ärztekammer Nordrhein/Paul-Ehrlich-Institut—Bundesamt für 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 Králové/State/Institute for Drug Control (Czech Republic). Written informed consent was obtained from all patients involved in this trial.

: Achim Rose and Herbert Rübben are Consultants for Innovacell Biotechnology AG.