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Article History

Received: 4 December 2017

Accepted: 9 July 2018

First Online: 31 July 2018

Ethics approval and consent to participate

: The Wales REC 3 granted approval on 27 May 2015 (15/WA/105), and clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) was granted on 15 April 2015 (21996/0002/001-0001). Informed consent was obtained from all participants in the study.

: Not applicable.

: NHW declares membership of the Health Technology Assessment (HTA) Primary Care, Community and Preventative Interventions Panel. DAH reports other grants from the National Institute for Health Research (NIHR) during the conduct of the study and membership of the HTA Clinical Trials Board from 2010 to 2016, the HTA Funding Teleconference from 2015 to 2016 and the Pharmaceuticals Panel from 2008 to 2012. EW reports receipt of other grants from NIHR during the conduct of the study. NEF declares membership of the HTA Primary Care, Community and Preventative Interventions Panel. DAW reports receipt of grants from Pfizer Ltd. and personal fees from Novartis Pharmaceuticals UK Ltd. and Pfizer Ltd. outside the submitted work. KK reports other grants from NIHR during the conduct of the study. JK reports receipt of personal fees from lectures (Pfizer Ltd., Merck & Co., Inc., and ORION Pharma GmbH), personal fees from a scientific advisory board (Axsome Therapeutics Inc.) and personal fees from stocks (ORION Pharma GmbH) outside the submitted work. SG reports receipt of grants from AbbVie Inc., Merck & Co., Inc., Pfizer Ltd., University Hospitals of Geneva, the Rheumasearch Foundation, Fondation de bienfaisance, Eugenio Litta and Centre de Recherches outside the submitted work.

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