Please select the eligibility criteria that correspond to the clinical trial below.
Title: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Brief Summary: The primary objective of the study was to compare the growth parameters of children approximately 2\* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(\* The mean age of subjects was 33.0 months due to a delay in the study start-up.)


Options:
A: Inclusion Criteria:

* Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study

Exclusion Criteria:

* Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
* Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
* Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study
B: Inclusion Criteria:

* Singleton, 10-14 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Anemia at time of birth
* Current use of iron or iron-containing supplements
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance
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 term newborns (the mean gestational age in weeks \> 36.0) with birth weight ≥2500 g appropriate for gestational age
* Apgar scores \> 7
* Uncomplicated early course of neonatal period
* Impossibility of breastfeeding (for infants randomized into the bottle-feeding groups)

Exclusion Criteria:

* The minimum possibility of breastfeeding (for infants randomized into the bottle-feeding groups)
* The diagnosis of a significant chronic medical condition including: HIV infection; cancer; bone marrow or organ transplantation; blood product administration within the last 3 mo; bleeding disorder; known congenital malformation or genetic disorder
* If the parent or legal guardian were unable to read and/or comprehend Chinese
* If the family moved outside of Beijing during the study period (i.e., would be unavailable for follow-up)

Answer: A