Funding for this research was provided by:
Received: 28 January 2020
Accepted: 18 June 2020
First Online: 13 July 2020
Ethics approval and consent to participate
: The study protocol, patient informed consent form to participate in the study and publish results and other required study documentation was initially reviewed and approved by the INSTITUTIONAL REVIEW BOARD (ETHICS COMMITTEE) OF CANTABRIA (CEIC), Region of Cantabria, Kingdom of Spain, prior to study start-up. This project was approved as a Research Project (Internal Code: 2018.001). Subsequently Ethical Committee approval in other fourteen centers in the Kingdom of Spain and other European Countries have been obtained (Centers in Croatia, Denmark, France, Germany, Greece, Italy, Portugal).Written informed consent is mandatory and obtained from all study participants.
: All participants will provide written consent for their personal or clinical details along with any identifying images to be published in this protocol publication.
: Principal investigators declare no financial and other competing interests for the overall trial and each study site.