In the event of infection, the study drug was discontinued, and routine clinical care was provided for the youngster by the family doctor or pediatrician. Children were not followed for much longer than 12 months. Secondary outcomes were urinary tract infection with fever on the basis of a clinically important decrease in the absolute risk of recurrent symptomatic urinary tract infection of approximately 10 %age points between your two groups during 12 months of follow-up, with around event rate of 29 percent in the placebo group.Results Patient-Years of Follow-up A total of 410 patients were signed up for the study between October 9, 2007, september 3 and, 2010 ; 406 of these patients began the process therapy . The first interim evaluation was performed at 167 patient-years, prior to the focus on accrual was reached, and the next interim analysis was performed following the accrual of 841 patient-years. Based on the strength of the data at the second analysis, the analysis team asked the board to consider early launch of the info from a third interim evaluation, that was performed after accrual of 1316 patient-years.