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This study was conducted in accordance with the ethical principles originating in the Declaration of Helsinki, the International Conference on Harmonization (ICH) Good Clinical Practice guidelines, and applicable regulatory requirements and in compliance with the protocol.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Janssen Research & Development, LLC facilitated the study design, provided writing assistance and editorial support for the manuscript, and reviewed and approved the manuscript prior to submission. The authors independently collected the data, interpreted the results, and made the final decision to submit the manuscript for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Role of the study sponsor"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"NF, SG, YG, PH, NP, QX and RV are employees of Janssen Research & Development and hold company stocks. VM has received consulting fees from Roche, Bayer, Pieris, BMS, Janssen, and Basilea. RP has received consulting fees from Karyopharm Therapeutics and Janssen, and Honoraria from MSD. EC has received research-related funding from AstraZeneca, Novartis, BeiGene and START Madrid. EC has received consulting and\/or advisory fees from Abbvie, Amcure, AstraZeneca, Celgene, EUSA Pharma, GLG, Guidepoint Global, Janssen-Cilag, Nanobiotix, Novartis, Pfizer, PsiOxus Therapeutics Limited, Roche\/Genentech, Seattle Genetics, SERVIER, and START Madrid. RG has been paid honoraria by MSD, BMS, Janssen, Lilly, Novartis, Bayer, Medison, Roche, Pfizer, Merck, and Takeda, paid for a consulting or advisory role by MSD, and had travel, accommodations, or other expenses paid for by BMS. TPY has received consulting and\/or advisory fees from MSD, Novartis, Medison, Pfizer, Astra Zeneca, Lilly, ProGenetics, and Roche.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}