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MSD supplied the study drug, supported investigator meetings, and provided clinical trial administrative and statistical analysis support for the collection and analysis of data; appropriate employees are also authors of this manuscript and participated in its development in accordance with ICMJE guidelines.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"J.A.M. reports personal fees and non-financial support from MSD, grants, personal fees and non-financial support from Pfizer Inc., grants, personal fees and non-financial support from Gilead Sciences, personal fees and non-financial support from F2G, and personal fees and non-financial support from Cidara. G.R., S. Haider, I.C.R. and A.P. have nothing to disclose. D.-G.L. has received grants and personal fees from Pfizer, Gilead Sciences, and Yuhan. N.K. has received research grants or honoraria as a speaker or advisor from Astellas, Gilead, MSD, and Pfizer. R.W. is an employee of Merck Sharp and Dohme LLC, a subsidiary of Merck and Co., Inc., Rahway, NJ, USA, and has stock in Merck and Co., Inc., Rahway, NJ, USA. G.A.W. is working under contract with Certara USA, Inc., Princeton, NJ, USA. S. Han, A.G., and H.W. are employees of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"The study was conducted in accordance with the principles of good clinical practice. The protocol and all amendments were reviewed and approved by the institutional review boards or independent ethics committees at all study sites before being initiated at each site.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All participants or their legal representatives gave written informed consent before initiation of any study procedures.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Publish"}},{"value":"The data sharing policy, including restrictions, of Merck Sharp and Dohme LLC, a subsidiary of Merck and Co., Inc., Rahway, NJ, USA is available at . Requests for access to the clinical study data can be submitted through the Engage Zone site or via email to dataaccess@merck.com.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"All authors approved the final version of the manuscript to be submitted. Additional specific contributions are detailed by author. J.A.M. contributed to the acquisition and analysis of data and  the interpretation of results and drafted, reviewed, and revised the manuscript. G.R. contributed to the acquisition of data and reviewed and revised the manuscript. D.-G.L. contributed to design of the study, acquisition and analysis of data, and the interpretation of results and drafted, reviewed, and revised the manuscript. S. Haider contributed to acquisition of the data and interpretation of results and reviewed and revised the manuscript. I.C.R. contributed to the acquisition of data and reviewed and revised the manuscript. N.K. contributed to the acquisition of data and reviewed and revised the manuscript. A.P. contributed to the acquisition of data and reviewed and revised the manuscript. S. H was involved in study design and reviewed and revised the manuscript. R.W. contributed to the study design, analysis of data, the interpretation of results, and drafting of the manuscript. G.A.W. contributed to the analysis of data and the interpretation of results and reviewed and revised the manuscript. A.G. contributed to the study design, acquisition and analysis of data, and the interpretation of results and reviewed and revised the manuscript. H.W. contributed to the study design, analysis of data, and the interpretation of results and drafted, reviewed, and revised the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}