Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Brief Summary: The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.


Options:
A: Inclusion Criteria:

* Males and non-pregnant ,non-lactating females 18 years or older
* Experience heartburn at least 2 days a week
* Having heartburn that has responded to heartburn medication
* Must discontinue any current heartburn medications

Exclusion Criteria:

* Having a history of erosive esophagitis verified by endoscopy
* Having a history of GERD which was diagnosed by a physician
* Inability to take study medication or complete the study and all study procedures
* Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
B: Inclusion Criteria:

* Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months.
* Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or, if PPI treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of PPI treatment
* Male or female, at least 18 years of age (for Austria, at least 19 years of age)
* Have given written informed consent
* Ability to read and write (literate)
* 7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)

Exclusion Criteria:

* Documented esophageal mucosal break
* History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer
* Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria:

  * Symptoms relieved by defecation
  * Symptoms associated with change in frequency of stools
  * Symptoms associated with change in form of stools
* Any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.
* Subjects with current or historical evidence of the following diseases/conditions

  * Zollinger Ellison syndrome
  * Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm
  * Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus
  * Evidence of upper gastrointestinal malignancy at the screening endoscopy
  * Gastric and/or duodenal ulcers within the last 2 years
  * Malabsorption
  * Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator
  * Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable
  * Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus
* Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy
* Use of PPIs for more than 5 days in the last 7 days prior to endoscopy
* Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study
* Need for continuous concurrent therapy with

  * NSAIDs (including selective COX II antagonists, salicylates (unless\<165 mg daily for cardiovascular prophylaxis)
  * anticholinergics
  * prostaglandin analogues
  * phenytoin
  * ketoconazole
  * itraconazole
  * warfarin and other vitamin K antagonists
* Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For South-Africa and Spain:

Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)

* Use of any other investigational compound 28 days prior to start and during the study
* Requirement of an interpreter (illiterate)
* Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator
* Previous participation in this study
* Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole
C: Inclusion Criteria:

* patients between the ages of 15 and 80 years
* with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
* who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.

Exclusion Criteria:

1. coexistence of peptic ulcer or gastrointestinal malignancies,
2. pregnancy,
3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
4. previous gastric surgery,
5. allergy to esomeprazole,
6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
D: Inclusion Criteria:

* Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

* Any condition that may require inpatient surgery during the course of the study.
* Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
* Use of antacids \[except for study supplied Gelusil®\].
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
* Evidence of uncontrolled systemic disease.
* Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
* Need to take blood thinners.
* Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
* Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
* Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
* Has had radiation or cryotherapy to the esophagus.
* Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
* Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
* History of alcohol abuse.
* Has acquired immunodeficiency syndrome.
* Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
* Received a blood product transfusion within 3 months of taking the first dose of study drug.
* Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.

Answer: D