MedPath

Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
Registration Number
NCT02433366
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

Detailed Description

Purpose:

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1213
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)Day 1

The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.

This Outcome measure is applicable only for the Physicians group.

Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)Day 1

The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (161)

Boehringer Ingelheim Investigational Site 113

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Sternberk, Czech Republic

Boehringer Ingelheim Investigational Site 29

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Besançon, France

Boehringer Ingelheim Investigational Site 35

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Eckwersheim, France

Boehringer Ingelheim Investigational Site 65

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Gruson, France

Boehringer Ingelheim Investigational Site 58

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Strasbourg, France

Boehringer Ingelheim Investigational Site 64

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Weyersheim, France

Boehringer Ingelheim Investigational Site 12

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Rostock, Germany

Boehringer Ingelheim Investigational Site 85

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Plovdiv, Bulgaria

Boehringer Ingelheim Investigational Site 79

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Montana, Bulgaria

Boehringer Ingelheim Investigational Site 90

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B?eclav, Czech Republic

Boehringer Ingelheim Investigational Site 87

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Sofia, Bulgaria

Boehringer Ingelheim Investigational Site 112

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Praha, Czech Republic

Boehringer Ingelheim Investigational Site 115

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Tehovec, Czech Republic

Boehringer Ingelheim Investigational Site 94

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?eský Krumlov, Czech Republic

Boehringer Ingelheim Investigational Site 98

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Havlí?k?v Brod, Czech Republic

Boehringer Ingelheim Investigational Site 102

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Krom??íz, Czech Republic

Boehringer Ingelheim Investigational Site 105

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Louny, Czech Republic

Boehringer Ingelheim Investigational Site 110

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Pardubice, Czech Republic

Boehringer Ingelheim Investigational Site 106

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Most, Czech Republic

Boehringer Ingelheim Investigational Site 108

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Odry, Czech Republic

Boehringer Ingelheim Investigational Site 134

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Lalinok, Slovakia

Boehringer Ingelheim Investigational Site 107

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Nový Bor, Czech Republic

Boehringer Ingelheim Investigational Site 116

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Teplice, Czech Republic

Boehringer Ingelheim Investigational Site 130

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Stranavy, Slovakia

Boehringer Ingelheim Investigational Site 80

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Shumen, Bulgaria

Boehringer Ingelheim Investigational Site 109

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Olomouc, Czech Republic

Boehringer Ingelheim Investigational Site 81

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Dobritch, Bulgaria

Boehringer Ingelheim Investigational Site 84

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Gabrovo, Bulgaria

Boehringer Ingelheim Investigational Site 86

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Sliven, Bulgaria

Boehringer Ingelheim Investigational Site 88

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Stara Zagora, Bulgaria

Boehringer Ingelheim Investigational Site 83

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Veliko Tarnovo, Bulgaria

Boehringer Ingelheim Investigational Site 82

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Varna, Bulgaria

Boehringer Ingelheim Investigational Site 92

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?eská Lípa, Czech Republic

Boehringer Ingelheim Investigational Site 93

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?eské Bud?jovice, Czech Republic

Boehringer Ingelheim Investigational Site 95

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Chomutov, Czech Republic

Boehringer Ingelheim Investigational Site 89

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Benesov u Prahy, Czech Republic

Boehringer Ingelheim Investigational Site 91

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Brno, Czech Republic

Boehringer Ingelheim Investigational Site 96

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Domazlice, Czech Republic

Boehringer Ingelheim Investigational Site 97

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Haví?ov, Czech Republic

Boehringer Ingelheim Investigational Site 99

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Ho?ovice, Czech Republic

Boehringer Ingelheim Investigational Site 101

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Ivan?ice, Czech Republic

Boehringer Ingelheim Investigational Site 100

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Hradec Králové, Czech Republic

Boehringer Ingelheim Investigational Site 103

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Kyjov, Czech Republic

Boehringer Ingelheim Investigational Site 104

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Liberec, Czech Republic

Boehringer Ingelheim Investigational Site 111

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Plze?, Czech Republic

Boehringer Ingelheim Investigational Site 114

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Tábor, Czech Republic

Boehringer Ingelheim Investigational Site 117

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Valasské Mezi?í?í, Czech Republic

Boehringer Ingelheim Investigational Site 25

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Ambleuteuse, France

Boehringer Ingelheim Investigational Site 69

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Copenhagen, Denmark

Boehringer Ingelheim Investigational Site 68

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Ardres, France

Boehringer Ingelheim Investigational Site 27

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Audincourt, France

Boehringer Ingelheim Investigational Site 26

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Arnac pompadour, France

Boehringer Ingelheim Investigational Site 28

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Bart, France

Boehringer Ingelheim Investigational Site 30

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Buissière galant, France

Boehringer Ingelheim Investigational Site 32

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Chalus, France

Boehringer Ingelheim Investigational Site 31

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Charbrignac, France

Boehringer Ingelheim Investigational Site 33

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Coussac Bonneval, France

Boehringer Ingelheim Investigational Site 34

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Decines, France

Boehringer Ingelheim Investigational Site 36

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Geneuille, France

Boehringer Ingelheim Investigational Site 37

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Glandon, France

Boehringer Ingelheim Investigational Site 39

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Lanouaille, France

Boehringer Ingelheim Investigational Site 38

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Halluin, France

Boehringer Ingelheim Investigational Site 67

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Le catelet, France

Boehringer Ingelheim Investigational Site 40

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Le Haillan, France

Boehringer Ingelheim Investigational Site 41

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Lille, France

Boehringer Ingelheim Investigational Site 42

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Limoges, France

Boehringer Ingelheim Investigational Site 45

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Marseille, France

Boehringer Ingelheim Investigational Site 43

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Lomme, France

Boehringer Ingelheim Investigational Site 44

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Lyon, France

Boehringer Ingelheim Investigational Site 60

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Thiviers, France

Boehringer Ingelheim Investigational Site 46

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Merignac, France

Boehringer Ingelheim Investigational Site 47

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Nexon, France

Boehringer Ingelheim Investigational Site 50

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Saint Martial d'Albarede, France

Boehringer Ingelheim Investigational Site 24

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Paris, France

Boehringer Ingelheim Investigational Site 48

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Noaillan, France

Boehringer Ingelheim Investigational Site 49

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Pompadour, France

Boehringer Ingelheim Investigational Site 52

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Saint Saud Lacousserie, France

Boehringer Ingelheim Investigational Site 51

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Saint Martin Sepert, France

Boehringer Ingelheim Investigational Site 53

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Saint Sornin Lavolps, France

Boehringer Ingelheim Investigational Site 54

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Saint Yrieix la Perche, France

Boehringer Ingelheim Investigational Site 55

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Saint-Hilaire-les-Places, France

Boehringer Ingelheim Investigational Site 56

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Schiltigheim, France

Boehringer Ingelheim Investigational Site 57

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Sochaux, France

Boehringer Ingelheim Investigational Site 59

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Talence, France

Boehringer Ingelheim Investigational Site 66

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Tourcoing, France

Boehringer Ingelheim Investigational Site 61

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Tourmignies, France

Boehringer Ingelheim Investigational Site 62

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Villenave d'Ornon, France

Boehringer Ingelheim Investigational Site 63

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Voujeaucourt, France

Boehringer Ingelheim Investigational Site 3

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Bremen, Germany

Boehringer Ingelheim Investigational Site 9

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Berlin, Germany

Boehringer Ingelheim Investigational Site 10

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Chemnitz, Germany

Boehringer Ingelheim Investigational Site 5

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Düsseldorf, Germany

Boehringer Ingelheim Investigational Site 6

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Essen, Germany

Boehringer Ingelheim Investigational Site 14

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Heidelberg, Germany

Boehringer Ingelheim Investigational Site 1

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Frankfurt, Germany

Boehringer Ingelheim Investigational Site 8

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Hannover, Germany

Boehringer Ingelheim Investigational Site 11

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Leipzig, Germany

Boehringer Ingelheim Investigational Site 138

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Puchov, Slovakia

Boehringer Ingelheim Investigational Site 7

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Marburg, Germany

Boehringer Ingelheim Investigational Site 2

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Mannheim, Germany

Boehringer Ingelheim Investigational Site 4

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Nürnberg, Germany

Boehringer Ingelheim Investigational Site 13

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München, Germany

Boehringer Ingelheim Investigational Site 122

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Banska Bystrica, Slovakia

Boehringer Ingelheim Investigational Site 127

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Bardejov, Slovakia

Boehringer Ingelheim Investigational Site 152

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 139

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Dolne Kockovce, Slovakia

Boehringer Ingelheim Investigational Site 143

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Radola, Slovakia

Boehringer Ingelheim Investigational Site 137

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Ivanka pri Dunaji, Slovakia

Boehringer Ingelheim Investigational Site 146

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Cierna nad Tisou, Slovakia

Boehringer Ingelheim Investigational Site 149

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Cierne Klacany, Slovakia

Boehringer Ingelheim Investigational Site 154

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Cierny Brod, Slovakia

Boehringer Ingelheim Investigational Site 141

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Horny Vadicov, Slovakia

Boehringer Ingelheim Investigational Site 140

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Jelka, Slovakia

Boehringer Ingelheim Investigational Site 159

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Kokava nad Rimavicou, Slovakia

Boehringer Ingelheim Investigational Site 125

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 158

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Kostany nad Turcom, Slovakia

Boehringer Ingelheim Investigational Site 155

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Liptovsky Hradok, Slovakia

Boehringer Ingelheim Investigational Site 160

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Krasno nad Kysucou, Slovakia

Boehringer Ingelheim Investigational Site 120

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Lastovce, Slovakia

Boehringer Ingelheim Investigational Site 157

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Poprad, Slovakia

Boehringer Ingelheim Investigational Site 145

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 144

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 119

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Nove Mesto nad Vahom, Slovakia

Boehringer Ingelheim Investigational Site 150

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Nove Zamky, Slovakia

Boehringer Ingelheim Investigational Site 124

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Odorin, Slovakia

Boehringer Ingelheim Investigational Site 142

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Oscadnica, Slovakia

Boehringer Ingelheim Investigational Site 128

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Povazska Bystrica, Slovakia

Boehringer Ingelheim Investigational Site 118

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Presov, Slovakia

Boehringer Ingelheim Investigational Site 132

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Povazsky Chlmec, Slovakia

Boehringer Ingelheim Investigational Site 153

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Resov, Slovakia

Boehringer Ingelheim Investigational Site 156

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Revuca, Slovakia

Boehringer Ingelheim Investigational Site 147

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Rozkovany, Slovakia

Boehringer Ingelheim Investigational Site 131

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Rudinka, Slovakia

Boehringer Ingelheim Investigational Site 126

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Sabinov, Slovakia

Boehringer Ingelheim Investigational Site 161

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Skalite, Slovakia

Boehringer Ingelheim Investigational Site 123

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Spisska Nova Ves, Slovakia

Boehringer Ingelheim Investigational Site 151

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Trnava, Slovakia

Boehringer Ingelheim Investigational Site 129

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Trnove, Slovakia

Boehringer Ingelheim Investigational Site 121

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Trebisov, Slovakia

Boehringer Ingelheim Investigational Site 148

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Vrable, Slovakia

Boehringer Ingelheim Investigational Site 135

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Valasska Bela, Slovakia

Boehringer Ingelheim Investigational Site 136

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Zvolen, Slovakia

Boehringer Ingelheim Investigational Site 133

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Zilina, Slovakia

Boehringer Ingelheim Investigational Site 22

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Barcelona, Spain

Boehringer Ingelheim Investigational Site 23

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Baleares, Spain

Boehringer Ingelheim Investigational Site 16

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Galicia, Spain

Boehringer Ingelheim Investigational Site 17

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Madrid, Spain

Boehringer Ingelheim Investigational Site 71

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Brighton, United Kingdom

Boehringer Ingelheim Investigational Site 15

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Ciudad Real, Spain

Boehringer Ingelheim Investigational Site 18

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Murcia, Spain

Boehringer Ingelheim Investigational Site 19

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Sevilla, Spain

Boehringer Ingelheim Investigational Site 20

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Valencia, Spain

Boehringer Ingelheim Investigational Site 76

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Cheadle, United Kingdom

Boehringer Ingelheim Investigational Site 78

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Essex, United Kingdom

Boehringer Ingelheim Investigational Site 21

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Zaragoza, Spain

Boehringer Ingelheim Investigational Site 73

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Romford, United Kingdom

Boehringer Ingelheim Investigational Site 77

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Manchester, United Kingdom

Boehringer Ingelheim Investigational Site 70

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London, United Kingdom

Boehringer Ingelheim Investigational Site 74

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Middlesex, United Kingdom

Boehringer Ingelheim Investigational Site 72

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Surrey, United Kingdom

Boehringer Ingelheim Investigational Site 75

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Stockport, United Kingdom

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