There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( 23.8 % and 24.5 % , respectively ; hazard ratio , 0.95 ; 95 % confidence interval [ CI ] , 0.77 to 1.18 ; P = 0.66 ) or between those who received M. indicus pranii immunotherapy and those who received placebo ( 25.0 % and 24.3 % , respectively ; hazard ratio , 1.03 ; 95 % CI , 0.82 to 1.29 ; P = 0.81 ) .