Please select the eligibility criteria that correspond to the clinical trial below.
Title: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Brief Summary: Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life


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:

* Previous participation in infant formula controlled protein study
* Body composition data from 6 month of age available
* Consent obtained from legal representative
* Within age parameters specified in protocol around the 3 and 5 year age points

Exclusion Criteria:

* Unable to endure testing procedures upon evaluation of the Investigator
* Outside the age range of the study
C: Inclusion Criteria:

* Gestational age at least 37 weeks
* Singleton birth
* Birth weight between 2500g and 4500g
* Weight at enrolment is at or above the 5th percentile (CDC)
* Infant has been exclusively formula fed for at least the last 14 days
* Having obtained informed consent of legal representative

Exclusion Criteria:

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Suspected or confirmed allergy to cow milk protein
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial
D: Inclusion Criteria:

. Healthy newborn infant

* Full term infant (= 37 weeks gestation; = 42 weeks gestation)
* Birth weight = 2500 g and \< 4200 g
* Singleton birth
* Infant is = 7 days of age at the time of enrollment
* For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
* Having obtained his/her or his/her legal representative's consent

Exclusion Criteria:

* Newborn whose mother's BMI was normal (\<20 or = 25) at start of pregnancy

  * Newborn whose mother had developed gestational diabetes during pregnancy
  * Newborn whose mother has diabetes of type-1 or type-2
  * Newborn whose mother smoked \> 5 cigarettes / day during pregnancy
  * Newborn whose mother had a drug dependence during pregnancy
  * Newborn whose mother has a chronic infectious disease
  * Newborn whose parents / caregivers cannot be expected to comply with treatment
  * Newborn currently participating in another clinical trial

Answer: A