Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Brief Summary: This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged\< 12 years with documented cow's milk protein allergy (CMPA).


Options:
A: Inclusion Criteria:

* Gestational age \> 37 weeks
* Appropriate for gestational age (above 10th percentile,Lubchenko)
* Age of the mother at least 18 years
* Singleton pregnancies
* Residence in the study area
* Maternal command of the language

Exclusion Criteria:

* Gestational diabetes
* Major malformations (of the child) which might interfere with nutrition or growth
* Hormonal or metabolic diseases of the mother or the child, drug addiction during pregnancy
B: Inclusion Criteria:

* Singleton, healthy infant
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 grams or greater
* Age between birth and 9 days of age
* Parents agree to not administer mineral or vitamin supplements during the study period
* Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

* Maternal, fetal or perinatal history which may have adverse effects on growth
* Multiple birth
C: Inclusion Criteria:

* Documentation of informed consent
* Inborn
* Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days
* If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
* No major anomalies
* Ability to begin parenteral nutrition within the first 48 hours after birth

Exclusion Criteria:

* Outborn
* Gestational age \< 23 weeks or \>= 30 weeks
* Any major congenital anomalies
D: Inclusion Criteria:

* Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

  * Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
  * Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum \[sIgE\>0,35 KUI/L\] or skin prick test \[SPT ≥ 3 mm\]) OR
  * Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
* Aged ≤12 years of age at screening.
* Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
* Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria:

* Children who receive breastfeeding at study enrolment.
* Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine \[excluding eye drops\] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
* Severe anaphylactic reaction \[required ≥ 2 doses of epinephrine\] to milk or breast milk within the past 2 years;
* Existing illness that could interfere with formula acceptance or identification of allergic reactions.
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Answer: D