Footnotes

• Handling editor Anna Maria Geretti

• Contributors ARR contributed to the writing of the article, performed medical visits and data collection. EB contributed to the writing of the article and data collection. BT contributed to data collection and the reviewing of literature. MFL contributed to the reviewing of the article. SN performed medical visits and contributed to the reviewing of the article. AC coordinated clinical activities and contributed to the reviewing of the article.

• 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.

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