Aknowledgements
We thank the patients and their families, the nurses, and the investigators who participated in this study. We also thank the data managers and the study coordinators at the coordinating center (Valeria Vicario, Manuela Florio, Antonia Del Giudice, Marilena Martino, Valentina Barbato, Simona Bevilacqua, Gaetano Buonfanti, Giuliana Canzanella, Giovanni De Matteis, Maria Teresa Ribecco, Fiorella Romano, Alfonso Savio).