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Optimal time between the last methotrexate administration and seasonal influenza vaccination in rheumatoid arthritis: post hoc analysis of a randomised clinical trial

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Footnotes

  • Contributors JKP, YC, KLW, YWS and EBL undertook data acquisition, analysis and interpretation and critical revision of the manuscript with respect to intellectual content. EBL had full access to all study data and takes responsibility for the integrity of the data and the accuracy of data analysis. JKP and EBL were responsible for study concept and design, and for drafting the manuscript.

  • Funding This study was sponsored by GC Pharma (formally known as Green Cross Corporation, Yongin-si, South Korea). The funder played no role in study design, data collection, data analysis, data interpretation or writing of the manuscript. The corresponding author had full access to all data and bears ultimate responsibility for the decision to submit for publication.

  • Competing interests EBL has acted as a consultant to Pfizer and has received research grants from GC Pharma and Hanmi Pharm.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the institutional review board of the Seoul National University Hospital (IRB 1608-158-787) and was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from all patients before enrolment in the trial. The study was registered with www.clinicaltrials.gov, protocol number: NCT02897011. The protocol allows use of stored sera for additional testing.