Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
Brief Summary: The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


Options:
A: Inclusion Criteria:

* patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
* patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

Exclusion Criteria:

* patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
* patients with a history of acute life-threatening event
B: Inclusion Criteria:

* At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study.
* Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.
* Must continue to have reflux symptoms during the Pretreatment Period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.
* The infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in \>25% of all feedings during the last 4 days of the Pretreatment Period as documented in the Daily Diary.

Exclusion Criteria:

* Body weight \<2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.
* Unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.
* Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus.
* Any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected.
* Use of a proton pump inhibitor within 30 days prior to Dosing Day 1.
* Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day 1.
* Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).
* Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the Pretreatment Period.
* Unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day 1.
* Clinically Significant abnormalities in clinical laboratory values.
C: Inclusion Criteria:

* Full-term or gestational age \>/= 28 to 44 weeks
* In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
* Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

* Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
* Patients with any condition that may require surgery during the course of the study
* Patients with acute respiratory distress within 72 hours prior to enrollment
D: Inclusion Criteria:

* History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months of screening
* Positive esophagogastroduodenoscopy
* Signed informed consent
* Female patients (if menstruating) must be practicing birth control

Exclusion Criteria:

* Patients with history of esophagitis
* Patients who have milk protein allergy
* Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
* Patients who have taken sucralate or any medication that affects gastrointestinal motility
* Patients with H. pylori
* Patients with lab values outside the normal age appropriate range
* Patients who have participated in another trial within 30 days before screening
* Patients with allergies to Proton Pump Inhibitors

Answer: C