text: There were no treatment-related serious adverse events ( SAEs ) , and the number of SAEs ( intervention 13.1 % [ 181/1 ,378 ] , control 12.7 % [ 174/1 ,374 ] , P = 0.712 ) and AEs ( intervention 10.5 % [ 144/1 ,378 ] , control 10.8 % [ 149/1 ,374 ] , P = 0.737 ) was similar .