Supplementary Material

Supplemental Table S1. Electronic diary

Diary / Questions / Response choices
Morning /
  1. Did you have any heartburn (burning or hurting in your throat, chest, or stomach) during the night last night?
/ Yes or no
  1. How much did the burning feeling in your throat, chest, or stomach hurt last night?
/ No heartburn; did not hurt very much; hurt some; hurt a lota
  1. Did you take any antacid during the night?
/ Yes or no
Evening /
  1. Did you have any heartburn (burning or hurting in your throat, chest, or stomach) during the day today?
/ Yes or no
  1. How much did the burning feeling in your throat, chest, or stomach hurt during the day today?
/ No heartburn; did not hurt very much; hurt some; hurt a lota
  1. Did you take any antacid during the day?
/ Yes or no
aMean degree to which daytime and nighttime heartburn was painful was calculated using the following scale: 0=report of no heartburn; 1=did not hurt very much; 2=hurt some; and 3=hurt a lot.

Supplemental Table S2. Definitions and severities of GERD symptoms asassessed by the investigator

Variable / Definition
Symptom
Heartburn / A burning feeling in the mid-epigastric area and/or chest area
Acid regurgitation / Flow of sour and bitter fluid into the mouth
Dysphagia / Difficulty in swallowing
Belching / The voiding of gas from the stomach through the mouth, which may have been associated with acid regurgitation
Epigastric pain / Central upper abdominal pain
Severity
None / No symptoms
Mild / Symptom did not last long and was easily tolerated
Moderate / Symptom caused discomfort and/or interrupted usual activities (including sleep)
Severe / Symptom caused great interference with usual activities and may have been incapacitating (including sleep)
Very severe / Symptom caused intense and constant discomfort and/or marked interference with usual activities (including sleep)

Supplemental Table S3. Concurrent medical conditions at baseline

Medical conditions reported by ≥5% of patientsa, n (%) / Patients (N=104)
Gastro-oesophageal reflux disease / 103 (99.0)
Seasonal allergy / 14 (13.5)
Drug hypersensitivity / 12 (11.5)
Constipation / 11 (10.6)
Asthma / 10 (9.6)
Headache / 10 (9.6)
Acne / 9 (8.7)
Abdominal pain / 8 (7.7)
Dysmenorrhoea / 8 (7.7)
Attention deficit/hyperactivity disorder / 6 (5.8)
Dyspepsia / 6 (5.8)
Gastritis / 6 (5.8)
aMedDRA (version 16.1) was used for coding the medical history.
GERD, gastro-esophageal reflux disease;MedDRA, Medical Dictionary for Regulatory Activities.