No statistical difference was observed between the two groups in the efficacy endpoints at Day 7 ( 0.0 % vs 7.7 % , P > 0.05 ) , Day 30 ( 0.0 % vs 7.8 % , P > 0.05 ) , 6 months ( 2.0 % vs 9.8 % , P > 0.05 ) and 1 year ( 2.2 % vs 9.8 % , P > 0.05 ) .