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Symptom Adapted Therapy in GERD Patients (SYMPATHY)

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
esomeprazole
Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Nexium

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Patients who seek medical advice in primary care for symptoms thought to be GERD-related Exclusion Criteria: Clinical GERD diagnosis/treatment within last 3 month History of severe esophagitis (i.e. LA grade C or D) Previous anti-reflux surgery History of drug abuse Female patients who are pregnant or lactating or at risk of pregnancy

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Outcomes

Primary Outcome Measures

To compare the efficacy of three different long-term treatment strategies in primary care setting
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Number of 'treatment failures' used as primary outcome variable.

Secondary Outcome Measures

To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale

Full Information

First Posted
June 20, 2006
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00343161
Brief Title
Symptom Adapted Therapy in GERD Patients
Acronym
SYMPATHY
Official Title
A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Nexium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Type
Drug
Intervention Name(s)
Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
Primary Outcome Measure Information:
Title
To compare the efficacy of three different long-term treatment strategies in primary care setting
Title
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Title
Number of 'treatment failures' used as primary outcome variable.
Secondary Outcome Measure Information:
Title
To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Title
Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
Title
To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
Title
To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Patients who seek medical advice in primary care for symptoms thought to be GERD-related Exclusion Criteria: Clinical GERD diagnosis/treatment within last 3 month History of severe esophagitis (i.e. LA grade C or D) Previous anti-reflux surgery History of drug abuse Female patients who are pregnant or lactating or at risk of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Höcker, MD
Organizational Affiliation
AstraZeneca Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joachim Labenz, MD
Organizational Affiliation
Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aiterhofen
Country
Germany
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City
Ansbach
Country
Germany
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City
Apolda
Country
Germany
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City
Bad Bramstedt
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Germany
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Bad Frankenhausen
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Germany
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Bad Salzuflen
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Germany
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City
Bad Schwartau
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Germany
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Baden-Baden
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Germany
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Bergkamen
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Germany
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Bergrheinfeld
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Bietigheim-Bissingen
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Germany
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Blankenhain
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Burgwedel
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Germany
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Dahn
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Germany
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Deggendorf
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Germany
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Deggingen
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Germany
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Dresden
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Germany
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Duisburg
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Germany
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Düsseldorf
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Germany
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Engstingen
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Germany
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Erfurt
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Ettlingen
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Germany
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Falkensee
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Germany
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Freudenberg
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Germany
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Fürstenwalde/Spree
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Germany
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Garching
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Germany
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Gefell
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Germany
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Gera
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Germany
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Gladbeck
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Germany
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Goch
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Germany
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Greven
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Germany
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Gärtringen
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Germany
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Görlitz
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Germany
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Hammelburg
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Germany
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Hamm
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Germany
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Heidelberg
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Germany
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Heilbronn
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Germany
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Heiligenstadt
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Germany
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Heroldsberg
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Germany
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Herrischried
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Germany
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Hoyerswerda
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Germany
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Ilmenau
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Germany
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Isernhagen
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Germany
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Kehl
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Germany
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Kirchlengern
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Germany
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Krefeld
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Germany
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Kronach
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Germany
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Kurort Oberwiesenthal
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Germany
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Köln
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Germany
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Landau
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Germany
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Leipzig
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Germany
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Leverkusen
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Germany
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Lohfelden
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Germany
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Löbau
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Germany
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Löhne
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Germany
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Lübbecke
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Germany
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Lübeck
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Germany
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Magstadt
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Germany
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Mülsen
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Germany
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Münster
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Germany
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Netphen
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Germany
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Neuss
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Germany
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Oettingen
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Germany
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Otterbach
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Germany
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Pforzheim
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Germany
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Plettenberg
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Germany
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Porta Westfalica
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Germany
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Rehmsdorf
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Germany
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Reinfeld
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Germany
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Rheinmünster-Greffern
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Germany
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Saarbrücken
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Germany
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Schnaittenbach
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Germany
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Schwerte
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Germany
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Siegen
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Germany
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Spalt
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Germany
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Stutensee
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Germany
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Sulzheim
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Germany
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Teterow
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Germany
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Thurnau
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Germany
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Uhingen
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Germany
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Urspringen
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Germany
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Viersen
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Germany
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Vilshofen
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Germany
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Waghäusel
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Germany
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Walsrode
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Germany
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Weinheim
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Germany
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Weißwasser
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Germany
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Wesseling
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Germany
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Wuppertal
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Germany
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Zwickau
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Germany

12. IPD Sharing Statement

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Symptom Adapted Therapy in GERD Patients

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