Congestive heart failure requiring hospitalization ( 3 [ 0.3 % ] versus 12 [ 1.4 % ] , OR : 0.23 , CI 0.06 to 0.85 , P = 0.027 ) was reduced and there was a trend of reduced cardio - / cerebrovascular events ( OM versus Pb : 73 [ 8.3 % ] versus 86 [ 9.8 % ] patients ) .