Paffoni, Alessio
Somigliana, Edgardo http://orcid.org/0000-0002-0223-0032
Sarais, Veronica
Ferrari, Stefania
Reschini, Marco
Makieva, Sofia
Papaleo, Enrico
Viganò, Paola
Funding for this research was provided by:
Italian Ministry of Health (RF-2013-02358757)
Article History
Received: 4 April 2019
Accepted: 26 September 2019
First Online: 1 November 2019
Ethics approval and consent to participate
: The study will be conducted in accordance to the ethical principles of the Helsinki Declaration guidelines.The study has been approved by the ethical committees of the two participating centres:- Comitato Etico Area B, Milan, protocol n° 602 05/04/2016- Comitato Etico Istituto di Ricovero e Cura a Carattere Scientifico - Ospedale San Raffaele, protocol n° 189/2016The study was approved by the Italian Medicines Agency (AIFA), protocol AIFA/RSCP/P/65768All participating women will sign a written informed consent, as approved by the Ethical Committees.Patients that are enrolled into the study are covered by indemnity for negligent/ non-negligent harm through a specific insurance to cover for harm associated with the protocol.In the event of any important modification to the study protocol, the principal investigator (E.S.) will inform study team members and trial participants via email/phone or in person.
: The manuscript will not contain individual personal person’s data. However, all participating women will sign an institutional authorization regarding the use of their clinical data for scientific publications.
: The authors declare that they have no competing interests.