Authors’ contributions
SL, CP, EG, GS, JRK, GI, TD, MM, JCM, DP, TOG, AS and SEA designed the clinical trial, developed the protocol and recruited patients. The statistics are done by MS. SL and AS wrote the manuscript. SL, CP, EG, GS, JRK, GI, TD, MM, JCM, DP, MS, TOG and SEA contributed to the development and finally approved the manuscript. The author(s) read and approved the final manuscript.