Author contributions
MV, FL, and GR conceived the original idea. MV and PR designed the study. MV and MC wrote the first draft of the manuscript and PR, FE, FL, and GR the final version. MT, FC, and MC performed flow cytometry analyses. AP and TP performed the statistical analyses. MV, MI, CC, and MA prepared the investigator brochure and the investigational medicinal product dossier. NR and FZ helped with data handling. SR, FZ, ILE, and MB included, managed, and monitored the patients. ADS reviewed and scored the quality of life questionnaires. All authors had full access to study data, contributed to data interpretation, and critically revised the manuscript. MV was the principal investigator of the study and was responsible for manuscript preparation and decision to submit for publication.