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(Incheon, Republic of Korea). Employees of the funder had a role in the study design, data analysis, data interpretation, and writing of the report and had access to the raw data. Employees of the funder had no role in data collection. The authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Chang-Hee Suh received consulting fees (<\u2009US$10,000) during the conduct of the study and grants outside the submitted work from CELLTRION, Inc. Dae Hyun Yoo is a scientific consultant (no fee), is on the speaker\u2019s bureau of CELLTRION, Inc., and has received research grants not related to this clinical study. Pedro Miranda received fees from CELLTRION for conducting the trial and has performed trials for CELLTRION outside the submitted work. Won Park and Seung Cheol Shim have received consulting fees (<\u2009US$10,000) from CELLTRION, Inc. Sang Joon Lee and Sung Young Lee are employees of CELLTRION, Inc. Alfredo Berrocal Kasay, Elias Chalouhi El-Khouri, Francisco Fidencio Cons Molina, Pavel Shesternya, Francisco G. Medina-Rodriguez, Piotr Wiland, Slawomir Jeka, Jose Chavez-Corrales, Thomas Linde, Pawel Hrycaj, Mauricio Abello-Banfi, Ihor Hospodarskyy, Janusz Jaworski, Mariusz Piotrowski, Marek Brzosko, Marek Krogulec, Sergii Shevchuk, Armando Calvo, and Daina Andersone have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The study was performed in accordance with the Declaration of Helsinki [] and Good Clinical Practice guidelines []. The study protocol was reviewed and approved by the relevant independent ethics committee at each site, and all patients provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}