Date Sharing Statement
We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendixes) will be shared. Individual participant data will be available beginning 3 months and ending one year following article publication. Supporting clinical documents including study protocol, statistical analysis plan (SAP), and the informed consent form (ICF) will be available immediately following publication for at least one year. Supporting clinical documents access information will be available at the following links. Researchers who provide a scientifically sound proposal will be allowed to access to the individual participant data. Proposals should be directed to firstname.lastname@example.org or email@example.com. These proposals will be reviewed and approved by the sponsor, investigator and collaborators on the basis of scientific merit. To gain access, data requestors will need to sign a data access agreement.