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This research was funded under Grant no. 2017NR7W5K_002 (PRIN 2017) from MIUR, Italy. All authors had full access to all the data in the study and accepted responsibility to submit for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Marzia Del Re: Ipsen, Novartis, Pfizer, Sanofi Genzyme, AstraZeneca, Pierre-Fabre, and Janssen (scientific advisory board, consulting relationship) and Ipsen, AstraZeneca, and Sanofi Genzyme (travel, accommodation, expenses). Romano Danesi: Ipsen, Novartis, Pfizer, Sanofi Genzyme, AstraZeneca, Janssen, Gilead, Lilly, Gilead, and EUSA Pharma (scientific advisory board, consulting relationship) and Ipsen and Sanofi Genzyme (travel, accommodation, expenses). Annamaria Mascolo, Cristina Scavone, Carmen Ferrajolo, Concetta Rafaniello, Antonio Russo, Enrico Coscioni, Francesco Rossi, Roberto Alfano, and Annalisa Capuano have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Safety data deriving from the spontaneous reporting system are anonymous and comply with ethical standards. Therefore, no further ethical measure was required.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable<b>.<\/b>","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated for this study will not be made publicly available but European pharmacovigilance data are available at .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"AM, CS, RA, and AC wrote the original draft. AM, CS, CF, CR, RD, MDR, AR, EC, FR, RA, and AC were responsible for the conceptualization, data curation, methodology, project administration, and the writing, review, and editing of the manuscript. AM, CS, CF, CR, RD, MDR, AR, EC, FR, RA, and AC were responsible for resources and investigation. All authors approved the final version of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}