Figure 1: Study schematic. Originally, 80 subjects were enrolled and randomized. Seventy-seven subjects with documented CMA in 6 months prior to enrollment were included in the modified ITT group. Thirty-six were randomized to receive Test formula during the first DBPCFC, and 41 to receive the Control formula. Two subjects discontinued from the 1st DBPCFC with Test while a total of 9 subjects discontinued the 1st DBPCFC with Control. The remaining 34 subjects in the group randomized to receive the Control formula for the 2nd DBPCFC completed that food challenge. The remaining 32 subjects who were randomized to receive the Test formula during the 2nd DBPCFC completed that food challenge. Therefore, a total of 68 subjects participated in a Test DBPCFC, and 75 subjects participated in a Control DBPCFC. Sixty-six subjects who completed both DBPCFCs without failing either one participated in the open week-long FC with the Test formula along with 1 subject from the original ITT analysis who was not diagnosed within 6 months prior to enrollment; this was not discovered until after completion of the open FC.