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Article History

First Online: 19 November 2020

Declarations

:

: This study was sponsored by Merck Serono S.A. (Geneva, Switzerland), an affiliate of Merck KGaA, Darmstadt, Germany. Representatives of Merck KGaA participated in the study design; collection, analysis and interpretation of the data; development of the trial report; and, in collaboration, with the authors developed the subsequent manuscript, and its submission for publication.

: Céleste Lebbé declares research funding from Roche, MSD, Bristol-Myers Squibb, and Novartis; reimbursement for travel from Bristol-Myers Squibb; and speaker bureaus for Roche, MSD, Bristol-Myers Squibb, Novartis, Pierre Fabré, and Sanofi. Antoine Italiano declares research funding from AstraZeneca, Bayer, Chugai, Merck, MSD, Pharmamar, and Roche; consulting fees or honoraria from AstraZeneca, Bayer, Roche, and Springworks; and reimbursement for travel from AstraZeneca and Roche. Ahmad Awada declares research funding from MSD and Roche; participation on advisory boards for Roche, Lilly, Puma Technology, Pfizer, Eisai Europe, Genoscience Pharma, Merck, Sopa Diagnostics, Bayer, Clovis Oncology, and Daiichi-Sankyo; and speaker bureaus for Lilly. Thierry Lesimple declares research funding from Roche; and reimbursement for travel or review activities from Bristol-Myers Squibb, MSD, Novartis, and Pierre Fabre Oncology. Jan H.M. Schellens declares research funding from Debiopharm and is a shareholder and employee of Modra Pharmaceuticals BV. Richard Kefford declares reimbursement for travel from Amgen. Eric Raymond declares consulting fees or honorarium from Genoscience Pharma and SCOR, and is a shareholder of Genoscience Pharma and SCOR. Sandrine Faivre declares consulting fees or honoraria from Blueprint, Bristol-Myers Squibb, Bayer, Ipsen, EMD Serono, MSD, and Roche. Armin Schueler is an employee and shareholder of Merck KGaA, Darmstadt, Germany. Samantha Goodstal is an employee of EMD Serono, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany). Giorgio Massimini is an employee and shareholder of Merck KGaA, Darmstadt, Germany. Jean-Pierre Delord declares consulting fees or honoraria from MSD, Bristol-Myers Squibb, Novartis, Roche, and Genentech. Nadine Houédé, Philippe Aftimos, Monica Dinulescu, Suzanne Leijen, Sylvie Rottey, Vibeke Kruse, Celine Pages, and Carlos Gomez-Roca declare no conflicts of interest.

: The protocol was approved and registered with the appropriate regulatory authorities and the study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements.

: Study concepts: ER, SF. Study design: ER, SF, JHMS, GM. Data acquisition: NH, ER, SR, SL, VK, CP, SF, PA, CL, RK, TL, JHMS. Quality control of data and algorithms: NH, SR. Data analysis and interpretation: NH, ER, SR, JHMS, SF, PA, AS, CL, SG, RK, TL, GM. Statistical analysis: AS. Manuscript preparation: TL, ER, CL. Manuscript editing: ER, SR, JHMS, SF, PA, CL, SG, NH. Manuscript review: J-PD, AI, AA, PA, NH, CL, CP, TL, MD, JHMS, SL, SR, VK, RK, SF, CG-R, AS, GM, ER, SG.

: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to Merck KGaA’s Data Sharing Policy. All requests should be submitted in writing to Merck KGaA’s data sharing portal (ExternalRef removed<u>)</u>. When Merck KGaA has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck KGaA will endeavor to gain agreement to share data in response to requests.