The safety outcome ( all-cause mortality , occurrence of malignancy , or hospitalization due to infection ) was not significantly different between the groups ( relative risk , 1.46 ; 95 % confidence interval , 0.63-3 .38 ) , neither was all-cause mortality at 6 months with 5 % versus 6 % ( relative risk , 0.78 ; 95 % confidence interval , 0.22-2 .80 ) .