Institutional Review Board Statement
This study was conducted in accordance with the Declaration of Helsinki and approved by the Independent Ethical Committee for Non-Pharmacological Clinical Studies, Genova, Italy (protocol code K.E.HU.NN.NGN00.000.00.00_2019/FV, approved on 13 November 2019). This study was registered at the ISRCTN registry with the following registration number: ISRCTN99047904.