Availability of data and materials {29}
The protocol and the results of the trial will be the exclusive property of the sponsor, who reserves the right to request on its behalf the industrial property rights that may derive from them. There are no agreements with other entities.The principal investigators are responsible for the preparation of the final report and therefore will have access to all available data. The anonymized data and the statistical code used for the analysis will be available from the principal investigators upon reasonable request.Data obtained from genomic studies will be deposited in repositories and databases and international public platforms such as the National Center for Biotechnology Information (NCBI).