Author contributions
RECRUITMENT
All authors reviewed and revised the manuscript and approved the final version for publication. JPM, LM, LP, ML, SDR, BA, RT, and TZ contributed by means of patient recruitment and follow-up and clinical data collection. HML and JMR were major contributors to study design and interpretation of results. DR was responsible for statistical analysis and generation figures and tables and contributed to the interpretation of results. MS was responsible for data accrual and integrity and interpretation of results. NH was responsible for interpretation of results and drafting the manuscript.