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Sganga is an employee of Catholic University of the Sacred Heart, Fondazione Agostino Gemelli University Hospital, Rome, Italy. M. Wang is an employee of Huashan Hospital, Fudan University, Shanghai, China. M.R. Capparella is an employee and shareholder of Pfizer PIO, Paris, France. M. Tawadrous, J.L. Yan and J.A. Aram are employees and shareholders of Pfizer Inc, USA. P. Montravers has no conflict of interest to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All primary studies were conducted in compliance with the Declaration of Helsinki and Good Clinical Practice Guidelines established by the International Conference on Harmonization. The final protocols, amendments and informed consent documentation were reviewed and approved by the Institutional Review Boards and the Independent Ethics Committees of the investigational centres.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}