In the full analysis set ( n = 130 ) , the proportion of patients without bloody stools was 76.9 % in the pH-2 .4 g and 69.2 % in the Time-2 .25 g , demonstrating the noninferiority of pH-2 .4 g to Time-2 .25 g. No statistically significant difference in time to bloody stools was found between the two formulations ( P = 0.27 , log-rank test ) , but the time to bloody stools tended to be longer in pH-2 .4 g compared to Time-2 .25 g , and a similar trend was observed with regard to the time to relapse .
