Footnotes

• Contributors AN, NP and MS were involved in ADR reporting and pharmacovigilance follow-up of the patients. AP, AN and LR were involved in study design and writing and reviewing the paper. AP, LR CS, RP, PB, AI and AM were engaged in patients' follow-up and enrolment.

• 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 Not required.

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