Growth and Safety Study of an Infant Formula for Healthy Term Infants

This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF)
infants. FF infants will be randomized to receive either a experimental infant formula,
formulated for healthy term infants (Formula B) or a commercially available infant formula
for healthy term infants (Formula A). Infants will consume the formula for a total of
16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be
assessed throughout the study.

Inclusion Criteria:

- Infants will be eligible to participate if they meet all of the following conditions.
At birth the infant must be:

1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no
greater than 41 weeks, 6 days), singleton infant

2. Have a birth weight of ≥ 2500 grams

At the time of the baseline/enrollment visit, infants must be:

3. Designated as healthy by a physician

4. ≤14 days post-natal age (Date of Birth = Day 0)

5. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific
World Health Organization (WHO) growth charts

6. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific
World Health Organization (WHO) growth charts

7. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to
sex-specific World Health Organization (WHO) growth charts

8. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to
sex-specific World Health Organization (WHO) growth charts

9. Exclusively consuming and tolerating a cow's milk infant formula at time of
enrollment; only infants whose parent(s) or legal guardian(s) have decided to
feed infant formula as the sole soure of nutrition, will be approached for
potential study enrollment

10. Have parent(s) or legal guardian(s) who agree to feed the study formula to the
study subject as his/her sole source of nutrition for the duration of the study

11. Have parent(s) or legal guardian(s) who have read and voluntarily signed an
Informed Consent form approved by the Institutional Review Board prior to any
participation in the study.

Exclusion Criteria:

Infants will be ineligible if they have any of the following conditions that are judged by
a physician to interfere with the infant's normal growth, development, and/or tolerance to
an infant formula:

1. Show evidence of anatomic and physiologic defects of the respiratory tract, or other
congenital defects (as determined by the clinician);

2. Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or
neurological diseases;

3. Have a maternal history with known adverse effects on the fetus and/or the newborn
infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight
is < 4300 g), active tuberculosis, perinatal infection, or substance abuse

4. Have a family history of cow's milk protein intolerance/allergy

5. Are an infant from a multiple birth (twin, triplet, etc.) -