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Article History

Received: 6 April 2020

Accepted: 1 November 2020

First Online: 24 November 2020

Ethics approval and consent to participate

: The DUBIUS study has been approved on 30 July 2015 by the Independent Ethics Committee competent for the University Hospital of Padova (Comitato Etico per la Sperimentazione Clinica della Provincia di Padova); for more details on the Ethics Committee, please refer to ExternalRef removed. The Ethics Committee approval is reported in the Ethical Approval Document. Moreover, the DUBIUS trial has been approved on 2 September 2015 by the Italian national competent authority (Agenzia Italiana del Farmaco, AIFA) (Additional file InternalRef removed). Any modifications to the protocol which may impact on the conduct of the study and potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects, will require a formal amendment to the protocol. Such amendment will be agreed upon by study sponsor and the steering committee and approved by the Ethics Committees prior to implementation and notified to the competent authorities in accordance with Italian and European regulations. Administrative changes of the protocol (such as minor corrections and/or clarifications that have no effect on the study conduction) will be agreed upon by the study sponsor and the steering committee and will be documented in the Trial Master File. The involved Ethics Committees will be notified of administrative changes by the sponsor. Informed consent will be obtained from all study participants.

: Not applicable. The manuscript does not report any individual person’s data in any form.

: S.R. reports a consulting fee from Astra Zeneca and a speaker’s fee from Eli Lilly; M.F. reports individual payment as consultant, for advisory board, or as a speaker at scientific congresses from Astra Zeneca, Eli Lilly, Chiesi Farmaceutici, Bayer, Sanofi, and Boehringer-Ingelheim; R.C. reports an advisory board fee from Astra Zeneca; F.S. reports speaker’s fees from Astra Zeneca and Daiichi Sankyo; F.V. reports consulting fees/honoraria from Astra Zeneca, Daiichi Sankyo, Bayer, Pfizer, Boehringer, Servier, Amgen, Sanofi, Piam, Alvi Medica, Teleflex, and Stenty. D.J.A. declares that he has received consulting fees or honoraria from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company and has received payments for participation in review activities from CeloNova and St Jude Medical. D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, and Renal Guard Solutions; in addition, D.J.A. is recipient of a funding from the Scott R. MacKenzie Foundation and the NIH/NCATS Clinical and Translational Science Award to the University of Florida UL1 TR000064 and NIH/NHGRI U01 HG007269. M.M. reports speaker’s fees from Astra Zeneca, Daiichi Sankyo, and Chiesi Farmaceutici, and that his institution has received an unconditioned research grant from Chiesi Farmaceutici. The other authors report no conflicts of interest.