Received: 23 July 2019
Accepted: 4 December 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study was not initiated until after the Medicines and Healthcare products Regulatory Agency had issued a Clinical Trial Authorisation, and the informed consent form and protocol were reviewed and approved by the ethics committee (National Research Ethics Service Committee North East – York, Reference number 15/NE/0218). Written informed consent was obtained from all individual participants included in the study.
: Not applicable.
: JB is a full-time employee of Covance, Clinical Research Unit, Leeds, UK. JB is also a LabCorp shareholder (Covance is a LabCorp-owned company). Covance was contracted by the sponsor, Fujifilm Kyowa Kirin Biologics Co., Ltd., to conduct this study. KK is an employee of Kyowa Hakko Kirin Co., Ltd. RM is an employee of Mylan Inc.