Author contributions
TB, JP, RP, D.B., SE
A.M., D.B., S.E., K.R., H.M. and Z.P. conceived and designed the clinical trial. AM, DB,AL, KR, ZP, JP, RP, AP, TM, FS,FS, KL carried out and delivered the clinical trial. AM., ZP., PA., DW., HC., IA., SE., TB., SH. performed the analyses. All authors read and approved the manuscript.