In the per-protocol analysis , ten ( 4 % ) of 250 patients had repair breakdown in the 7 day group ( 95 % CI 2-8 ) compared with eight ( 3 % ) of 251 ( 2-6 ) in the 14 day group ( risk difference 08 % [ 95 % CI -28 to 45 ] ) , meeting the criteria for non-inferiority .