Marco Colleoni, MD, Weixiu Luo, MS, Prof Per Karlsson, MD, Jacquie Chirgwin, MD, Prof Stefan Aebi, MD, Prof Guy Jerusalem, MD, Prof Patrick Neven, MD, Erika Hitre, MD, Marie-Pascale Graas, MD, Edda Simoncini, MD, Claus Kamby, MD, Prof Alastair Thompson, MD, Prof Sibylle Loibl, MD, Joaquín Gavilá, MD, Katsumasa Kuroi, MD, Prof Christian Marth, MD, Bettina Müller, MD, Prof Seamus O’Reilly, MD, Prof Vincenzo Di Lauro, MD, Andrea Gombos, MD, Thomas Ruhstaller, MD, Harold Burstein, MD, Karin Ribi, PhD, Prof Jürg Bernhard, PhD, Prof Giuseppe Viale, MD, Rudolf Maibach, PhD, Manuela Rabaglio-Poretti, MD, Prof Richard D Gelber, PhD, Prof Alan S Coates, MD, Angelo Di Leo, MD, Meredith M Regan, ScD, Prof Aron Goldhirsch, MD, on behalf of the SOLE Investigators