Infant Formula in Infants and Children With Cow's Milk Allergy

Inclusion Criteria:

• Participant's parent(s) is/are willing for their child to undergo confirmatorytesting or must have had at least one of the following within 6 months ofenrollment:

1. Physician diagnosis of IgE-mediated CMA, according to the participant'sclinical history (e.g. gastrointestinal symptoms, hives, respiratory symptomsor angioedema) AND, detectable serum milk-specific IgE >0.7 kUᴀ/L or positiveskin prick test wheal ≥5 mm;

2. Documentation of milk-specific serum IgE >15 kUᴀ/L or > 5 kUᴀ/L if younger than 1 year;

3. Documented cow's milk skin prick test wheal >10mm;

4. Physician-supervised oral food challenge that elicited immediate, objective,allergic symptoms.

• Participant's parent(s) agree for their child to stop oral steroid use within 14days and antihistamine use within 7 days of confirmation of diagnosis and foodchallenges.

• Participant had followed a strict cow's milk protein-free diet for at least 2 weeksprior to enrollment.

• Parent(s) confirm their intention not to administer any products containing cow'smilk protein during the study.

• Participant is between 3 months and 12 years of age at enrollment.

• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation inthe study.

Exclusion Criteria:

• Participant is partially or exclusively breastfed at the time of enrollment.

• Participant is consuming an amino acid-based formula due to failure on anextensively hydrolyzed formula.

• Significant chronic medical diseases including major chromosomal or congenitalanomalies, gastrointestinal diseases, or abnormalities other than CMA,immunodeficiencies, unstable asthma, eczema and/or food allergies treated withbiologics (omalizumab or other monoclonal antibody), FPIES, eosinophilicesophagitis, and severe uncontrolled eczema.

• Previous severe anaphylactic reaction to cow's milk within the last two years.,

• An adverse medical history or current condition that is thought by the investigatorto have potential for effects on tolerance or the hypoallergenicity test.

• Participant has an allergy or intolerance to any ingredient in the study product, asreported by the parent.

• Participant is consuming baked milk products.

• Use of and/or changing dose of high potency steroids.