Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial
Brief Summary: This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.


Options:
A: Inclusion Criteria:

Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
2. Age ≤ 7 days after birth (date of birth = Day 0)
3. Full-term gestational birth (≥ 37 and ≤ 42 weeks)
4. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2
5. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
6. Weight ≥ 2'500 g and ≤ 4'200 g
7. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
8. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion Criteria:

Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:

1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
4. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
5. Received radiation therapy (eg. scannography or interventional radiology)
6. Participation in any other clinical trial prior to enrollment
7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
B: Inclusion Criteria:

* good health
* singleton birth with gestational age 37-42 weeks
* infant's birth weight \>or = to 2500 grams
* exclusive breastfeeding or exclusively formula feeding
* within a defined geographical boundary
* mother has no problems communicating in English

Exclusion Criteria:

* adverse maternal, fetal or infant medical history
* congenital disease or malformation affecting growth or development
* illness or social problems in mother or infant
* temporary residents
C: Inclusion Criteria:

* healthy
* singleton
* full-term infants (gestational age 37/0 to 41/6 weeks)
* birth weight adequate for gestational age (\>p10 and \<p90 for gestational age) according to the World Health Organization growth charts.

Exclusion Criteria:

* presence of congenital diseases
* presence of chromosomal abnormalities
* presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
* being born to mother affected by endocrine and/or metabolic diseases
* having a family history of allergic disease
D: Inclusion Criteria:

* Healthy term infants;
* Age 0-8 days of age;
* Exclusively formula fed;
* No use of vitamin/mineral supplements.

Exclusion Criteria:

* Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Answer: C