Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
Brief Summary: The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.


Options:
A: 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
B: Inclusion Criteria:

* Having obtained his/her parents' (or his/her legally accepted representative \[LAR's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
* Child was born full term (≥ 37 weeks of gestation)
* Age at enrollment: between 11.5 months and 13.5 months of age
* 2.5 kg ≤ birth weight ≤ 4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
* Cows' milk allergy
* Lactose intolerance
* Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
* Infant who is being breastfed at the time of enrollment
* Infant who does not usually drink 300ml of cow's and/or formula milk per day
* Institutionalized children
* Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
C: 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
D: Inclusion Criteria:

* Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
* Birth weight of greater than or equal to 2500 grams.
* Designated healthy by a physician.
* Less than or equal to 14 days of age at enrollment.
* If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
* If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
* Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
* Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
* Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
* Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

Exclusion Criteria:

* Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
* Infants required to take medications know to influence growth and development.
* Maternal history with known adverse effects on the fetus and/or the newborn infants.
* Family history of cow milk protein allergy or soy intolerance/allergy.
* Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
* Infants from a multiple birth.

Answer: A