Suh, Chang-Hee
Yoo, Dae Hyun
Berrocal Kasay, Alfredo
Chalouhi El-Khouri, Elia
Cons Molina, Francisco Fidenci
Shesternya, Pavel
Miranda, Pedro
Medina-Rodriguez, Francisco G.
Wiland, Piotr
Jeka, Slawomir
Chavez-Corrales, Jose
Linde, Thomas
Hrycaj, Pawel
Abello-Banfi, Mauricio
Hospodarskyy, Ihor
Jaworski, Janusz
Piotrowski, Mariusz
Brzosko, Marek
Krogulec, Marek
Shevchuk, Sergii
Calvo, Armando
Andersone, Daina
Park, Won
Shim, Seung Cheol
Lee, Sang Joon
Lee, Sung Young
Funding for this research was provided by:
Celltrion Inc
Article History
First Online: 5 February 2019
Compliance with Ethical Standards
:
: This work was supported by CELLTRION, Inc. (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.
: Chang-Hee Suh received consulting fees (< US$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’s 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 (< US$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.
: The study was performed in accordance with the Declaration of Helsinki [CitationRef removed] and Good Clinical Practice guidelines [CitationRef removed]. The study protocol was reviewed and approved by the relevant independent ethics committee at each site, and all patients provided written informed consent.