The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups ( 100 [ 82 % ] of 122 vs 45 [ 87 % ] of 52 ; p = 0.51 ) and ( 33 [ 27 % ] of 122 vs 18 [ 35 % ] of 52 ; p = 0.36 ) , respectively .