Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

Inclusion Criteria:

1. Infants <8 months of age.
2. Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospitalpractice, including any of the following criteria:
3. Based on clinical examination with a careful history, parent-reported symptomssuggestive of CMA, and disappearance of the symptoms when cow's milk waseliminated from the diet for at least two weeks prior to study entry
4. Based on clinical examination with a careful history, parent-reported symptomssuggestive of CMA, and disappearance of the symptoms while being breastfed withmaternal cow's milk protein elimination diet for at least two weeks prior tostudy entry
5. History of CoMiSS® score >10 indicating symptoms are likely cow's milk allergicprior to study entry
6. History of positive result of an oral food challenge with cow's milk prior tostudy entry
7. Presence of specific Immunoglobulin E (IgE) to cow's milk protein based on skinprick test (wheel size ≥3mm) or radio-allergosorbent-test (RAST) (>0.7 kilounitper liter (kU/L)) prior to or on the day of study entry.
8. 3. Infants that are still on dairy-derived extensively hydrolysed formula, aminoacid-based formula, hydrolysed rice protein formula, soy-based formula or beingbreastfed by mothers who are on cow's milk protein elimination diet at study entry.
9. Parents / guardians confirm their intention not to administer any products containingcow's milk protein during the study.
10. Expected to consume the specified age-dependent minimum amount of study product perday during the study.
11. Expected to require a milk substitute for CMA management for at least 16 weeks.
12. Written informed consent provided by parents / guardians, according to local law.

Exclusion Criteria:

1. Birth weight-for-age z-score <-2 Standard Deviation (SD) or >+2SD.
2. Infants <37 weeks gestation requiring specific premature formula at the time of studyentry.
3. Infants with severe concurrent illness and/or have undergone gastrointestinal surgerysuch as bowel resection or stoma placement and/or with Down syndrome or othersyndromes where functional gastrointestinal disorders are common.
4. Infants that are more suitable to use Amino Acid Formula (AAF) as first-line formula,including but not limited to those with high risk of anaphylaxis (prior history ofanaphylaxis and currently not using extensively Hydrolysed Formula (eHF)), falteringgrowth / failure to thrive, or severe forms of non-IgE-mediated CMA such aseosinophilic oesophagitis, enteropathies, or Food Protein-Induced EnterocolitisSyndrome (FPIES).
5. Infants with diagnosis of rice allergy or known allergy to any of the ingredients inthe study product.
6. Investigator's uncertainty about the willingness or ability of the parents / guardiansto comply with the protocol requirements.
7. Participation in any other studies involving investigational or marketed productsconcomitantly or within two weeks prior to entry into the study.