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Article History

Received: 20 July 2022

Accepted: 22 September 2022

First Online: 11 October 2022

Funding

: Laboratori Guidotti and Malesci, Italy (ExternalRef removed; ExternalRef removed) provided unconditional financial support to the study including the journal’s Rapid Service Fee.

: All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published and agree to be accountable for all aspects of the work.

: Members of the STORICO Study Group Pietro Schino (Acquaviva delle Fonti); Giuseppina Cuttitta (Palermo); Maria Pia Foschino (Foggia); Renato Prediletto (Pisa); Carmelindo Mario Enrico Tranfa (Napoli); Maria Cristina Zappa (Roma); Pasquale Patriciello (Pollena Trocchia); Luciana Labate (Bari); Salvatore Mariotta (Roma); Stefano Nava (Bologna); Alessandro Vatrella (Salerno); Michele Mastroberardino (Avellino); Riccardo Sarzani (Ancona); Antonio Iuliano (Milano); Lamberto Maggi (Bergamo); Anna Zedda (Casoria); Alberto Pesci (Monza); Giuseppe Sera (Torino); Antonello Nicolini (Sestri Levante); Salvatore Walter Di Donato (Mondragone); Silvia Forte (Roma); Mario Del Donno (Benevento); Federica Rivolta (Abbiategrasso); Mauro Ferliga (Chiari); Antonio Filippo Raco (Menaggio); Luigi Di Re (Teramo); Gaetano Cabibbo (Modica); Rosario Maselli (Catanzaro); Carlo Gulotta (Orbassano); Stefano Nardini (Vittorio Veneto); Enrico Eugenio Guffanti (Casatenovo); Walter Castellani (Firenze); Luca Triolo (Roma); Giovanni Passalacqua (Messina); Bianca Beghè (Modena); Salvatore Lo Cicero (Milano); Enzo Faccini (Dolo); Elena Atzeni (Nuoro); Roberto Tazza (Terni); Piercarlo Giamesio (Asti).

: B.F. reports grants and personal fees from ASTRAZENECA, grants and personal fees from BAYER, personal fees from CHIESI, personal fees from GSK, personal fees from GUIDOTTI, grants and personal fees from GRIFOLS, grants from INSMED, personal fees from MENARINI, personal fees from NOVARTIS, grants and personal fees from PFIZER, personal fees from TEVA, personal fees from ZAMBON, outside the submitted work. S.L. and A.O. are employees of Medineos Observational Research. S.B. is employee of Laboratori Guidotti. C.G. was employee of Laboratori Guidotti when the research was conducted. The other authors declare that they have no competing interests.

: The study was approved by the Ethic Committee of the coordinating center (Fondazione Toscana G. Monasterio Pisa, Italy) and was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practices guidelines for observational studies, complying with all requirements of local regulations. Patients provided written, informed consent before study participation.

: The data that support the findings of this study are available from authors and Laboratori Guidotti, Italy but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. There are legal and ethical restrictions since data contain potentially sensitive patient information. Data are however available from the authors and Laboratori Guidotti upon reasonable request. Data request may be sent to the first author (R.Antonelli@unicampus.it) and to Stefania Barsanti (Laboratori Guidotti, sbarsanti@labguidotti.it). Clara Giovanetti changed here affiliation respect to affiliation at the time of the study. Here new affiliation is reported: Grifols Italy SpA, Via Torino 15—56,010 Vicopisano (PI), Italy—clara.giovannetti@grifols.com.