Author contributions
ADS: study concept and study design, supervision, data analysis and interpretation, first version of writing. MJB: data analysis and interpretation, first version writing and revision. SG, SC, FF, GM, PDL, AI, SO, AC, FG, GMP, ILM: collection of clinical data. ADS and MJB interpretation of final data and definition of conclusions. SC, FF, PDL and AC: review of the literature. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. ADS, MJB, SG and ILM have directly accessed and verified the underlying data reported in the manuscript.