Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Inclusion Criteria:

* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities
B: Inclusion Criteria:

* Endoscopically proven GERD diagnosed within 6 months before study entry.
* Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria:

* History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
* Subjects 6-11 years old unable to swallow tablets
C: 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.
D: 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

Answer: A