Dissemination policy
BLIND
The data will be owned by the promoter and will be shared with the investigators. Ownership of study data will remain with the investigators involved. The results of the study will be published and may also be the subject of communications, reports, or posters at congresses. The results of the study will be made available for publication.The promoter will be responsible for study design, supervision of the study and its conduct according to Good Clinical Practice, the final processing of the data, and dissemination of the study results.The main investigators of each center will be responsible for recruiting patients and compiling the eCRF.The principal investigator of the coordinating center will inform the ethics committee of the center of any modification to the study protocol in order to obtain a new approval. Subsequently, he will notify the principal investigator of each center and the respective ethics committees of this changes in order to obtain the local approval. There is currently no public access to the original protocol, dataset, or statistical code. The available information is currently deposited on the clinicaltrials.gov website. NCT05198375.All presentations and publications are expected to protect the integrity of the major objectives of the study; data that break the blind will not be presented prior to the release of mainline results.