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Margeli has received advisory fees from Novartis, Lilly and Menarini, speakers\u2019 honoraria from Pfizer, Novartis and Lilly and travel support from GILEAD, Pfizer and Roche. The rest of authors declare that no funds, grants, or other support were received during the preparation of this manuscript.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Yes, available. This study was conducted in compliance with the Declaration of Helsinki, the Good Clinical Practice Guidelines of the International Conference for Harmonisation (GCP\/ICH) and all applicable Spanish legislation. The study protocol of the original GEICAM\/2003-02 clinical trial was approved by the corresponding institutional review boards and The Spanish Agency of Medicines and Medical Devices. The current study was approved by the Autonomous University of Madrid- Ethics committee (CEI-137- 2939) as part of an ongoing A. 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