Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
Brief Summary: The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.


Options:
A: Inclusion Criteria:

* Body weight is greater than or equal to 30 kg.
* Females of childbearing potential who are sexually active must agree to use an acceptable form of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as determined from the Cockcroft-Gault formula.
* Participants who take prescription or non-prescription proton pump inhibitors, histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage throughout the study.
* Must have a history of gastroesophageal reflux disease symptoms, as documented by a physician, for at least 2 months prior to Screening or is currently symptomatic.
* Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion Criteria:

* Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
* Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the trial or that would contraindicate taking dexlansoprazole MR or a similar drug in the same class.
* Has a known hypersensitivity to any proton pump inhibitors or any component of the formulation of dexlansoprazole MR (see most current version of the Investigator Brochures).
* Has a history of malignant disease.
* Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody.
* Has a known history of infection with the human immunodeficiency virus.
* Has donated or lost greater than or equal to 300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
* Is required to take or intends to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
* Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice while participating in the study.
* Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
* Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
* Has participated in a study of an investigational agent (including dosing or follow up) within 30 days prior to first dose of study drug.
* Has an initial Screening Visit or Day -1 laboratory value that the principal investigator considers to be clinically significant.
* Participant is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped homozygous non-wild type).
* Is unlikely to comply with the protocol or is unsuitable for any other reason per the opinion of the investigator
B: 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
C: 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
D: 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

Answer: B