Data management
All information required by the protocol will be entered in the eCRF. Data will be collected as they are obtained. Any missing data will be coded. Every site will have access to the eCRF via a web-based data collection system. Investigators will be given a document offering guidance on using this tool. Each investigator will be responsible for the accuracy, quality and relevance of all the data entered. An audit trail of all changes will be saved. The computer file used for this research is implemented in accordance with French (amended “Informatique et Libertés” law governing data protection) and European (General Data Protection Regulation – GDPR) regulations. The sponsor has obtained the authorization of the CNIL (“