There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) or between those who received M. indicus pranii immunotherapy and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .