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Michelino De Laurentiis received speaker\u2019s honoraria and advisory board honoraria from Amgen, AstraZeneca, Celgene, Eisai, Eli Lilly, MSD, Novartis, Pfizer, and Roche, outside the submitted work. Claudio Zamagni received honoraria from Takeda, Pierre Fabre, Teva, and Instituto Gentili; consulting or advisory board fees from Roche, Eisai, Novartis, AstraZeneca, Pfizer, PharmaMar, Celgene, Eli Lilly, Amgen, Tesaro, and QuintilesIMS; research funding paid to institution from Roche\/Genentech, Roche, AstraZeneca, Novartis, Medivation, AbbVie, Pfizer, Array BioPharma, Morphotek, Celgene, Tesaro, Synthon, and Seattle Genetics;\u00a0and reimbursement of travel or accommodation expenses from Roche, Celgene, Novartis, Pierre Fabre, Instituto Gentili, Pfizer, Tesaro, and PharmaMar, outside the submitted work. Igor Kudryavcev has nothing to disclose. Mari\u00ebtte Agterof has nothing to disclose. Ursa Brown-Glaberman received advisory board honoraria from Novartis, Eisai, Seattle Genetics, and BioTheranostics, outside the submitted work. Mark\u00e9ta Pal\u00e1cov\u00e1 has nothing to disclose. Sanjoy Chatterjee has nothing to disclose. Lakshmi Menon-Singh is an employee of Novartis Pharmaceuticals and holds stock or options to hold stock in the company. Jiwen Wu is an employee of Novartis Pharmaceuticals and holds stock or options to hold stock in the company. Miguel Mart\u00edn received research grants from Roche, Puma Biotechnology, and Novartis; consulting\/advisory fees from AstraZeneca, Amgen, Taiho Oncology, Roche\/Genentech, Novartis, PharmaMar, Eli Lilly, Puma Biotechnology, Daiichi Sankyo, and Pfizer; and speaker\u2019s honoraria from AstraZeneca, Amgen, Roche\/Genentech, Novartis, and Pfizer, outside the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"CompLEEment-1 was designed, implemented, and reported in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonised Tripartite Guidelines for Good Clinical Practice, applicable local regulations, and the ethical principles laid down in the Declaration of Helsinki. The protocol and informed consent form were reviewed and approved by a properly constituted Institutional Review Board\/Independent Ethics Committee\/Research Ethics Board before study commencement. A steering committee oversaw the trial conduct, as per the approved protocol. Representatives of the trial sponsor, Novartis Pharmaceuticals (East Hanover, NJ), collected and analysed the data.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all patients.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}