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Competing interests JMF has received grants or research support from Daiichi Sankyo, Novartis and NIH and is a consultant or on a steering committee for Novartis, NIH, Daiichi Sankyo, Boehringer Ingleheim. He is also on the speakers bureau for Novartis, Daiichi Sankyo, Boehringer Ingleheim. SAN and PDL have no conflicting interests.