Data management {19}
Patient data needed for the study will be collected in an e-CRF. This e-CRF, developed via the Ennov Clinical software, will be specific to the study.The patient code (see the paragraph “The e-CRF will only include the data needed to analyze the efficacy and safety of patients and for publication (information required by the protocol). Other data relating to the patient and necessary for their follow-up outside the study will be collected in their medical file. An explanation will be provided for each missing data.At the end of the study, a paper print will be requested, which must be authenticated (dated and signed) by the investigator. A copy of the authenticated document for the sponsor must be archived by the investigator.