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Article History

Received: 8 May 2017

Accepted: 22 November 2017

First Online: 16 January 2018

Ethics approval and consent to participate

: The PRESERVE trial was conducted in accordance with the ethical principles of the Declaration of Helsinki and the guidelines for Good Clinical Practice of the International Conference on Harmonisation. All patients were required to sign an informed consent form. The institutional review board or independent ethics committee at the following participating centers reviewed and approved all consent forms and the PRESERVE study protocol: Australia – Bellberry Limited, Dulwich, SA; Flinders Clinical Research Ethics Committee, Repatriation General Hospital, Daw Park, SA; The Austin Health Human Research Ethics Committee, Heidelberg, VIC. Austria – Ethikkommission der Stadt Wien, Wien. Belgium – Comite d'ethique Hospitalo-Facultaire Universitaire de Liege, Centre Hospitalier Universitaire du Sart Tilman, Liege; CHU Liege, Comité d’Ethique de la Faculté de Médicine, Centre Hospitalier Universitaire du Sart Tilman, Liege. Chile – Comite Etico Cientifico, Servicio de Salud Metropolitano Oriente, Santiago, RM. Colombia – Comite de etica de la fundacion instituto de reumatologia Fernando Chalem, Bogota, Cundinamarca; Comité de etica independiente centro de reumatologia y ortopedia, Barranquilla, Atlantico; Comite de Etica de la Investigacion Riesgo de Fractura S.A., Bogota, Cundinamarca. Czech Republic – Eticka komise Fakultni nemocnice Olomouc a Lekarske fakulty, Univerzity Palackeho, Olomouc; Ethics Committee of Institute of Rheumatology, Praha; Eticka komise pro multicentricka klinicka hodnoceni Fakultni nemocnice v Motole, Praha; Multicentricka eticka komise Fakultni nemocnice u sv. Anny v Brne - detasovane pracoviste, Brno. France – Comité de Protection des Personnes, Sud-Ouest et Outre-Mer II Hôpital Purpan, Toulouse Cedex 9. Germany – Ethik-Kommission bei der Medizinischen Fakultaet der Universitaet Wuerzburg, Institut fuer Pharmakologie und Toxikologie, Wuerzburg. Hungary – Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga, Budapest. Italy – Comitato Etico Scientifico dell'Azienda Ospedaliera Ospedale Niguarda Ca' Granda di Milano, Milano; Comitato Etico Azienda Ospedaliera Universitaria San Luigi Gonzaga di Orbassano, Orbassano; Comitato Etico dell'Universita' Campus Bio-Medico di Roma, Roma; Comitato Etico dell'Azienda Ospedali Vittorio Emanuele, Ferrarotto, S.Bambino, Catania. Republic of Korea – Institutional Review Board, Gangnam Severance Hospital, Seoul; Institutional Review Board/Ethics Commitee of Kangdong Sacred Heart Hospital, Seoul; Hallym University Sacred Heart Hospital Institutional Review Board, Anyang-Si, Gyeonggi-do; Institutional Review Board for Human Research, Konkuk University Hospital, Seoul; Institutional Review Board, Gachon Gil Medical Center, Incheon; Hanyang University Hospital IRB, Seoul; IRB of Eulji University Hospital, Daejeon. Mexico – Comite de Etica de la Facultad de Medidna de la UANL Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey NL; Comite Bioetico para la Investigacion Clinica S. C., Puebla 422, Mexico, DF; Comite de Etica del Hospital San Javier, Guadalajara, Jalisco; Comité de Investigación del Hospital CEM, Merida, Yucatán. The Netherlands – Independent Review Board Nijmegen (IRBN) Nijmegen, Wijchen. Poland – Komisja Etyczna Przy Instytucie Reumatologicznym ul Spartanska 1, Warszawa. Russian Federation - Biomedical Ethics Committee at FGU "Severo-Zapadny District Medical Center of Rozdrav," St. Petersburg; Ethical council under responsibility of department of state regulation of circulation of medicines, Ministry of Public Health and Social Development of Russian Federation, Moscow; Local Ethics Committee at GU Institute of Rheumatology of RAMS, Moscow; Local Ethics Committee at GUZ "City Clinical Hospital #1 n.a., N.I.Pirogov," Rheumatology Department, Moscow; Local Ethics Committee at GUZ at Leningrad Regional Clinical Hospital, St. Petersburg; Local Ethics Committee at Moscow Regional Research Clinical Institute, n.a. M.F. Vladimirskogo, Moscow. Serbia and Montenegro – Ethics Committee of Institute of Rheumatology-Belgrade, Belgrade; Ethics Committee of Institute for Treatment and Rehabilitation "Niska Banja," Niska Banja; Ethics Committee Military Medical Academy, Belgrade. Spain – Hospital General Universitario Gregorio Marañon, Comite etico de Investigacion Clinica c/Doctor, Madrid. Sweden – Regionala etikprovningsnamnden i Uppsala, Uppsala. Taiwan – Institutional Review Board of Tri-Service General Hospital National Defense Medical Center, Neihu, Taipei; Kaohsiung Medical University Chung-Ho Memorial Hospital, Institutional Review Board, Kaohsiung. United Kingdom – Liverpool Adult Research Ethics Committee, Research Ethics Office, Liverpool; Wrightington, Wigan and Leigh LREC, Greater Manchester Strategic Health Authority, Manchester; West Midlands Research Ethics Committee, Redditch, Worcestershire.

: Not applicable.

: JSS has received research grants and consulting fees from AbbVie, BMS, MSD, Pfizer, and Roche, and consulting fees from Astra-Zeneca, Boehringer Ingelheim, Celgene, Celtrion, GSK, ILTOO, Janssen, Lilly, Novartis-Sandoz, Samsung, and UCB. AS is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support for the development of this paper. ASK, TVJ, and LM are employees of Pfizer and hold Pfizer stock. The authors do not report any non-financial conflicts of interest.

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