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This study was sponsored by EirGenix, Inc., which provided financial support for the conduct of the trial. The sponsor did not have any role in the study design, data collection, data analysis, or interpretation of the results. The sponsor reviewed the manuscript for scientific accuracy during the revision process but did not influence the decision to publish or the final content of the manuscript. Chiun-Sheng Huang, Giorgi Dzagnidze, Barbara Grohmann-Izay, Lee-Cheng Liu, N\u00e9stor Llin\u00e1s-Quintero, Ae-Ning Lin, Anand Kumar Mishra, Denys Pominchuk, Aliaksandr Prokharau, Bernardo Leon Rapoport, Vladimir Semiglazov, Ling-Ming Tseng, Eduardo Ya\u00f1ez Ruiz, and Sibylle Loibl had full access to the study data and take responsibility for the integrity of the data and the accuracy of the data analysis.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The protocol for study EGC002 was approved by local competent authorities and ethics committees of each participating site. All patients included in the study provided written informed consent. The trial was carried out in accordance with the ethical principles of the Declaration of Helsinki (1964) and its later amendments, the International Council for Harmonization Good Clinical Practice Guidelines, and all applicable local regulatory requirements. The full details of the independent ethics committees and institutional review boards for the study are provided in the supplementary material. All patients included in the study provided written informed consent to participate.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}