Visit 1 Visit 2 Overall   n (%) n (%) n (%) 95% confidence interval lower bound Subject has any allergic reaction? Test Formula       0.921 (92.1%) Yes 1 (2.8%) 0 (0.0%) 1 (1.5%)   No 35 (97.2%) 32 (100%) 67 (98.5%) Control Formula       0.869 (86.9%) Yes 3 (7.3%) 1 (2.9%) 4 (5.3%)   No 38 (92.7%) 33 (97.1%) 71 (94.7%)

Table 3: Summary of subjects with allergic reactions (Yes/No) by formula and visit (mITT population, defined as any subject who consumed any amount of formula during the DBPCFC).