Treatment failure was detected in 94 ( 22.8 % ) and 94 ( 23.0 % ) patients in intention-to-treat analysis ( risk difference 0.2 % ; 95 % CI : -5.5 % -6.0 % ) and in 80 ( 20.1 % ) and 85 ( 21.3 % ) patients in per-protocol analysis ( risk difference 1.2 % ; 95 % CI : -4.4 % -6.8 % ) .