Footnotes

• Handling editor Josef S Smolen

• Contributors IM and TO wrote the first draft of the manuscript. IM and GS conceptualised the study and review the final version of the manuscript. IP, EM and MVM revised the final draft of the manuscript. All the authours followed the patients during their follow-up.

• Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

• Competing interests None declared.

• Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

• Provenance and peer review Not commissioned; externally peer reviewed.