Footnotes

• Contributors YR, NP, JM, RMF and JAO analysed the clinical data. YR, RMF and JAO participated in the writing of the first draft of the manuscript. JAO is responsible for the whole content of the article. All authors planned the study, collected the clinical data and have read and agreed with the last version of the manuscript.

• 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 consent for publication Obtained.

• Ethics approval Institutional (CIREN) scientific ethics committee.

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