Elemental Formula Hypoallergenicity

Inclusion Criteria:

- Born at term (>36 weeks gestation)

- 2 months to ≤12 years of age at enrollment

- Documented CMA within 6 months prior to enrollment

- Otherwise healthy

- Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable

- Expected daily intake of at least 8 oz (240ml) of the study formula during the open
challenge phase

- Having obtained his/her legal representative's informed consent

Exclusion:

- Children consuming mother's milk at the time of inclusion and during the trial

- Any chromosomal or major congenital anomalies

- Any major gastrointestinal disease or abnormalities other than CMA

- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems
(heart murmurs okay)

- Immunodeficiency

- Anti-histamine use in 7 days prior to the first food challenge (eyedrops are
permitted)

- Oral steroid use within 14 days prior to enrollment (intranasal and topical
corticosteroid use are permitted)

- Unstable asthma

- Severe uncontrolled eczema

- Severe anaphylactic reaction to milk within the last 2 years

- Severe anaphylactic reaction to breastmilk within the last 2 years

- Subject who in the Investigator's assessment cannot be expected to adhere to the
study protocol

- Currently participating in another clinical trial.