D’Amario, D.
Restivo, A.
Leone, A. M.
Vergallo, R.
Migliaro, S.
Canonico, F.
Galli, M.
Trani, C.
Burzotta, F.
Aurigemma, C.
Niccoli, G.
Buffon, A.
Montone, R. A.
Flex, A.
Franceschi, F.
Tinelli, G.
Limbruno, U.
Francese, F.
Ceccarelli, I.
Borovac, J. A.
Porto, I.
Crea, F.
Funding for this research was provided by:
AstraZeneca SpA (POR-TAP-16-007)
Article History
Received: 4 April 2019
Accepted: 29 January 2020
First Online: 17 February 2020
Ethics approval and consent to participate
: The study has been independently reviewed and approved by the respective Ethics Committee of A. Gemelli Polyclinic of the Catholic University of the Sacred Heart in Rome , Italy (definitive approval 23 Nov. 2017, prot. No. 48133/17, ID: 1605; AIFA approval 21 Aug. 2017, prot. No. AIFA/SC/P/90531).All patients will be voluntarily included in this trial and will be officially enrolled once the informed written consent has been signed. The Principal Investigator or his delegates are responsible for obtaining a written informed consent from each subject. The Principal Investigator or his delegates will explain the nature of the trial, its purpose, the procedures involved, the expected duration, the potential risks and benefits involved, and any discomfort it may entail and provide the subject with a copy of the Informed Consent fully signed. The subject will be given sufficient time to consider the trial before deciding whether to participate. Each subject must be informed that participation in the trial is voluntary and that he/she may withdraw from the trial at any time and that withdrawal of consent will not affect his/her subsequent medical treatment or relationship with the treating physician. All patients are to provide written informed consent in accordance with applicable laws of the country. The patient will sign and date the informed consent form before he/she enters the study (i.e., before any study-related activity). The Principal Investigator or his delegates will explain the nature of the study, its purpose and the expected duration. The patient will be given sufficient time to consider the study before deciding whether to participate. Each patient must be informed that participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her medical treatment or relationship with the treating Investigator. In the case of an amendment that would directly affect the patient’s participation in the study, the patient must provide new written informed consent indicating that he/she re-consents to participate in the study.This trial will be carried out in compliance with the protocol, designed to ensure adherence to Good Clinical Practice, as described:1. ICH Harmonised Tripartite Guidelines for Good Clinical Practice, 1996. Note for Guidance on Good Clinical Practice CPMP/ICH/135/95 (and subsequent revisions).2. EU Directive 2001/20/EC, 2005/28/EC and its receipt in local laws.3. Declaration of Helsinki (1964, and its amendments and subsequent clarification).The Principal Investigator agrees, when signing the protocol, to adhere to the instructions and procedures described in it and thereby to adhere to the principles of Good Clinical Practice to which it conforms. To the same extent, any of his delegates will be bound to the same compliance.Any protocol modifications such as changes to eligibility criteria, outcomes, pre-specified analyses, etc. will be disclosed to relevant parties, respective Ethics Committees at both participating centers, trial participants, and the trial registry in which this study has been registered.Personal information of potential and enrolled participants will be collected at the dedicated computer system and will be password-protected and available only to site investigators. Confidentially of patients will be protected before, during, and after the trial. Fondazione Policlinico Universitario Agostino Gemelli will have access to the final trial dataset.
: Not applicable.
: The authors declare that they have no competing interests.