Funding for this research was provided by:
Damor Pharmaceuticals (ID0ETQAG3399)
Text and Data Mining valid from 2018-05-24
Received: 15 February 2018
Accepted: 10 May 2018
First Online: 24 May 2018
Ethics approval and consent to participate
: The study protocol, the patient information sheet, the informed consent form, the letter to general practitioner and the “privacy statement” sheet were examined and approved by the reference Ethic Committee of the investigational study site (Italian National Health Institute. Comitato Etico Area Vasta Nord Ovest [CEAVNO] Toscana, Pisa, Italy) prior to any study-related procedure was started. The study initiation was notified to the Italian Ministry of Health. The study was conducted according to the principles defined in the Declaration of Helsinki and amendments, and to the procedures of Good Clinical Practice (whenever applicable), expressed in the guideline set out by the International Conference on Harmonization. The decision on study participation was freely and in written taken by the patient, and it was clarified that the consent could have been withdrawn at any time, without penalty or loss of patient’ rights of benefits.
: The authors declare that they have no competing interests.
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