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FM holds a minor share of Novartis and has a patent pending: \u201cCancer Treatment with a HER2 Inhibitor\u201d. RGT is an employee of ICON and was the principal investigator of the trial. The authors received no payment related to the development of this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was performed in line with the ethical principles that have their origin in the Declaration of Helsinki (October 1996 version), and the ICH Harmonized Tripartite Guideline for Good Clinical Practice and all applicable regulations. The study was approved by an independent ethics committee of Stichting Beoordeling Ethiek Biomedisch Onderzoek, Assen, The Netherlands (EU CT number 2022-503047-17-00).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"All participants provided written informed consent to participate in the study prior to the initiation of any study specific procedures.","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"}},{"value":"Data to support the findings in this study are included in the manuscript or its supplementary information. Additional data can be made available from the corresponding author on reasonable request.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). RG, DJ, GG, AMA, RGT, HHW, RL, SW, PMR, BH, FM, and DM conceptualized and designed this study; RGT was responsible for investigational medicinal product preparation, clinical conduct, participant safety and laboratory analyses; RG, DJ, GG, AMA, HHW, RL, SW, PMR, BH and DM acquired data for the study analysis; all authors analyzed and\/or interpreted the data; RG, DJ, GG, AMA, RGT, HHW, RL, SW, BH, FM, and DM drafted the paper, all authors critically reviewed and revised the paper. All authors have read and agreed to the published version of the manuscript and to be accountable for all aspects of the work. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}