Conflict of interest
LP served as a consultant for Dompé farmaceutici spa Milan, Italy.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.The original clinical trial was funded by Dompé farmaceutici spa Milan, Italy. Each study center received research support and compensation from Dompé farmaceutici spa Milan, Italy to conduct the study and collect data.