Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Brief Summary: To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Options:
A: Inclusion Criteria:

* the participant must have a mother, biological father or sibling with type 1 diabetes
* the participant must carry a susceptible HLA genotype(HLA-DQB1\*02 and/or DQB1\*0302 without protective alleles (DQB1\*0301, \*0602 and \*0603)

Exclusion Criteria:

* no telephone
* no accessibility to any of the research centers
* inability of parents to understand the study and instructions
* unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
* gestational age less than 36 weeks
* Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
* the newborn infant has received any cow's milk-based product prior to randomization
B: Inclusion Criteria:

- The infant's parents give signed consent to participate and their HLA genotype is eligible.

Exclusion Criteria:

* An older sibling of the newborn infant has been included in this study;
* Multiple gestation;
* The parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural);
* The gestational age of the newborn infant is less than 35 weeks
* Inability of the family to take part in the study (e.g. the family had no access to the Study Center or telephone)
* The newborn infant has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.;
* The infant receives any infant formula other than study formula or Nutramigen at the delivery hospital
* No HLA sample has been drawn before the age of 8 days.
C: Inclusion Criteria:

* Biological parent and/or full (not half) sibling of the newborn infant had type 1 diabetes as defined by the World Health Organization
* The infant's parent or legal guardians gave signed consent to participate

Exclusion Criteria:

* An older sibling of the newborn infant had been included in the TRIGR intervention
* Multiple gestation
* The parents were unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
* The newborn infant had a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
* The gestational age of the newborn infant was less than 35 weeks.
* The infant was older than 7 days at randomization.
* Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
* The infant had received any infant formula other than Nutramigen prior to randomization.
* No HLA sample drawn before the age of 8 days.
D: Inclusion Criteria:

* Singleton birth
* Term infant at birth
* Birth weight of 2500 g (5 lbs 8 oz) or more
* 4 - 18 days of age at Study Visit 1

Exclusion Criteria:

* History of underlying metabolic or chronic disease or congenital malformation
* Infant switched formulas more than one time between birth and Study Visit 1
* Known feeding problems at Study Visit 1

Answer: D