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Footnotes
Handling editor Josef S Smolen
Contributors All authors meet the journal’s criteria for authorship. All authors have contributed to the work and approve the presented findings.
Funding This study was funded by Janssen Research & Development.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study protocols were reviewed and approved by an independent ethics committee or institutional review board for each study centre. This study is registered at EudraCT (number: 2013-001417-32) and ClinicalTrials.gov (number: NCT02019472).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data are included in this letter and attached tables and figures.
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