Ethical considerations
Developed as a consequence of the Declaration of Helsinki, Ethical Principles regarding the conduct of clinical research involving humans (World Medical Association-WMA, 1964) and of the Oviedo Convention (EU, 1997) are required by the Italian NHS Research Ethics Committee.
Participants involved will be completely informed about the aim of the study and will be asked to sign an individual paper consent form. Women will be free to decline participation or to retire any moment. Data will be stored securely on hospital storage and IT platform protected by password (Data Protection Code, 2003; GDPR, 2018).
Ethical approval for this study was obtained from the Milano Area 1 Ethics Committee (N°46091, November 7th, 2018) prior to the commencement of the research. All respondents will be provided the name, telephone number, and email of the Principal Investigator and the Iocal Review Board’s contact details, in case of any question about the study.