Plans to give access to the full protocol, participant level-data, and statistical code {31c}
In conformity with the Good Clinical Practice:The sponsor is responsible for obtaining the agreement of all the parties implicated in the study in order to guarantee direct access to all the sites where the study will take place, to the source data, source documents, and reports, in the interests of quality control and audits by the sponsor;The investigators will provide the persons responsible for the follow-up, the quality control, or the audit of the study involving human individuals, the individual documents, and data that are strictly necessary for this control, in accordance with the current legal and regulatory provisions (article L1121-3 and R.5121–13 of the public health code).The statistical code will be available upon request to the biostatistician in charge of data analysis.