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PVA has received travel support from Astellas, Novartis, Chiesi, Sandoz and speaker fees from Alexion and Mallinkrodt. GJP has received travel support from Sandoz. NE has received travel support from Novartis, Astellas and Chiesi. IR received speaker fees from Novartis and travel support from Sandoz, Pfizer y Astellas. FT has received DSMB fees from ImClone, Daiichi-Sankyo Pharma Development, ArQule and Rovi and speaker fees from Bayer. JMC has had consultancy agreements with Pfizer, Wyeth, Novartis and Roche; has received research funding from Pfizer and Novartis; and has been a scientific advisor or board member for Novartis and Pfizer and has received lecture fees from Alexion. JR has received DSMB fees from SOLTI and speaker fees in biostatistical education from SOLTI, Boehringer Ingelheim, Grunenthal, AMGEN and Novartis without relation of the present work. FD has received research grants and speaker fees from Astellas, Neovii, Novartis, Pfizer, Teva, Transplant Biomedicals. FO has received speaker fees from Novartis, Sanofi and Neovii and travel support from Novartis. AMJ, ENM, EDSA, FC, MS, JVT and MJR reported no conflict of interest. The results presented in this paper have not been published previously in whole or part, except in abstract format","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical statement"}}]}}