Data availability
The data that support the findings of this study are available from the corresponding author (jessica.mandrioli@unimore.it) to external researchers who provide methodologically sound scientific proposals and whose proposed use of the data has been approved by an independent review committee identified for this purpose. All requests will be reviewed by corresponding author and Steering Committee of the Study and response to requests will be given in 2 months. A materials transfer and/or data access agreement with the study promoter will be required for accessing shared data. However, individual participant data will not be available because informed consent did not explicitly include this. Source data are provided as Source Data files with this paper. The study protocol, including the statistical analysis plan has been uploaded in the Supplementary Information file. 