Funding for this research was provided by:
Fondazione Cassa di Risparmio di Modena
Università Degli Studi di Modena e Reggio Emila (135246)
Received: 7 March 2019
Revised: 9 May 2019
Accepted: 4 July 2019
First Online: 29 July 2019
Ethics approval and consent to participate
: The MiFrAADiF trial was conducted under Local Ethics Committee approval (protocol no. 2621/C.E.). The written consent and the case report form were reviewed by the Local Ethics Committee. The participants’ written consent was obtained prior to the enrollment. The trial was registered in ExternalRef removed (NCT03276312) and conducted in compliance with applicable regulatory requirements in accordance with the revised provisions of the Helsinki Declaration and in adherence with Good Clinical Practice. Confidentiality was maintained with all patient records.
: The informed consent was obtained by all the patients. No personal details were included.
: The authors declare that they have no competing interests.