MedPath

Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Completed
Conditions
Parkinson's Disease
Registration Number
NCT01061567
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1814
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
Proportion of Patients With Withdrawals Due to Adverse Events.16 weeks

Patients who discontinued treatment due to adverse events including deaths.

Incidence of Adverse EventsFrom the treatment initiation to the end of study, on average 92.9 days

The number of patients with any adverse events (AEs), patients with drug-related AEs.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item ScoreBaseline and the end of study (up to 16 weeks)

The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total ScoreBaseline and the end of study (up to 16 weeks)

Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement.

Clinical Global Impression of Improvement (CGI-I) Responder RateBaseline and the end of study (up to 16 weeks)

The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.

Change From Baseline in Visual Analogue Scale (VAS) of Patient SatisfactionBaseline and the end of study (up to 16 weeks)

The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction.

Trial Locations

Locations (284)

Boehringer Ingelheim Investigational Site 115

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Järvamaa, Estonia

Boehringer Ingelheim Investigational Site 2

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Bad Radkersburg, Austria

Boehringer Ingelheim Investigational Site 19

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Graz, Austria

Boehringer Ingelheim Investigational Site 20

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Grieskirchen, Austria

Boehringer Ingelheim Investigational Site 7

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Deutschlandsberg, Austria

Boehringer Ingelheim Investigational Site 8

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Dornbirn, Austria

Boehringer Ingelheim Investigational Site 10

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Ehenbichl, Austria

Boehringer Ingelheim Investigational Site 11

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Eisenstadt, Austria

Boehringer Ingelheim Investigational Site 12

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Eisenstadt, Austria

Boehringer Ingelheim Investigational Site 17

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Graz, Austria

Boehringer Ingelheim Investigational Site 21

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Grimmenstein, Austria

Boehringer Ingelheim Investigational Site 15

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Gänserndorf, Austria

Boehringer Ingelheim Investigational Site 25

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Hartberg, Austria

Boehringer Ingelheim Investigational Site 27

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Hohenems, Austria

Boehringer Ingelheim Investigational Site 43

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Laßnitzhöhe, Austria

Boehringer Ingelheim Investigational Site 67

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Salzburg, Austria

Boehringer Ingelheim Investigational Site 42

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Kufstein, Austria

Boehringer Ingelheim Investigational Site 72

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St. Pölten, Austria

Boehringer Ingelheim Investigational Site 76

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Tullnerbach-Lawies, Austria

Boehringer Ingelheim Investigational Site 78

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Villach, Austria

Boehringer Ingelheim Investigational Site 81

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Vöcklabruck, Austria

Boehringer Ingelheim Investigational Site 100

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Wien, Austria

Boehringer Ingelheim Investigational Site 104

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Wien, Austria

Boehringer Ingelheim Investigational Site 87

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Wien, Austria

Boehringer Ingelheim Investigational Site 94

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Wien, Austria

Boehringer Ingelheim Investigational Site 97

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Wien, Austria

Boehringer Ingelheim Investigational Site 99

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Wien, Austria

Boehringer Ingelheim Investigational Site 110

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Zirl, Austria

Boehringer Ingelheim Investigational Site 111

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Zwettl, Austria

Boehringer Ingelheim Investigational Site 195

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Bacau, Romania

Boehringer Ingelheim Investigational Site 196

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Bacau, Romania

Boehringer Ingelheim Investigational Site 197

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Baia Mare, Romania

Boehringer Ingelheim Investigational Site 198

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Baia Mare, Romania

Boehringer Ingelheim Investigational Site 116

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Rakvere, Estonia

Boehringer Ingelheim Investigational Site 113

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Tallinn, Estonia

Boehringer Ingelheim Investigational Site 117

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Tartu, Estonia

Boehringer Ingelheim Investigational Site 120

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Viljandi, Estonia

Boehringer Ingelheim Investigational Site 118

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Valga, Estonia

Boehringer Ingelheim Investigational Site 283

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Almaty, Kazakhstan

Boehringer Ingelheim Investigational Site 194

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Bacau, Romania

Boehringer Ingelheim Investigational Site 199

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Botosani, Romania

Boehringer Ingelheim Investigational Site 200

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Brasov, Romania

Boehringer Ingelheim Investigational Site 201

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Brasov, Romania

Boehringer Ingelheim Investigational Site 203

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 204

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 205

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 206

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 207

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 208

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 209

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 210

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 214

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 216

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 211

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 217

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 218

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 219

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 220

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Buzau, Romania

Boehringer Ingelheim Investigational Site 221

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Buzau, Romania

Boehringer Ingelheim Investigational Site 222

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Campulung, Romania

Boehringer Ingelheim Investigational Site 223

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Cluj-Napoca, Romania

Boehringer Ingelheim Investigational Site 234

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Focsani, Romania

Boehringer Ingelheim Investigational Site 225

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Constanta, Romania

Boehringer Ingelheim Investigational Site 229

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Craiova, Romania

Boehringer Ingelheim Investigational Site 230

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Craiova, Romania

Boehringer Ingelheim Investigational Site 232

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Craiova, Romania

Boehringer Ingelheim Investigational Site 226

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Constanta, Romania

Boehringer Ingelheim Investigational Site 231

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Craiova, Romania

Boehringer Ingelheim Investigational Site 238

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Iasi, Romania

Boehringer Ingelheim Investigational Site 239

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Iasi, Romania

Boehringer Ingelheim Investigational Site 241

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Oradea, Romania

Boehringer Ingelheim Investigational Site 242

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Oradea, Romania

Boehringer Ingelheim Investigational Site 243

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Piatra Neamt, Romania

Boehringer Ingelheim Investigational Site 247

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Ploiesti, Romania

Boehringer Ingelheim Investigational Site 250

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Ramnicu Valcea, Romania

Boehringer Ingelheim Investigational Site 244

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Piatra Neamt, Romania

Boehringer Ingelheim Investigational Site 251

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Ramnicu Valcea, Romania

Boehringer Ingelheim Investigational Site 259

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Suceava, Romania

Boehringer Ingelheim Investigational Site 252

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Ramnicu Valcea, Romania

Boehringer Ingelheim Investigational Site 256

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Sibiu, Romania

Boehringer Ingelheim Investigational Site 269

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Tulcea, Romania

Boehringer Ingelheim Investigational Site 255

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Sibiu, Romania

Boehringer Ingelheim Investigational Site 257

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Simleul Silvaniei, Romania

Boehringer Ingelheim Investigational Site 258

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Slobozia, Romania

Boehringer Ingelheim Investigational Site 261

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Targoviste, Romania

Boehringer Ingelheim Investigational Site 266

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Timisoara, Romania

Boehringer Ingelheim Investigational Site 270

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Tulcea, Romania

Boehringer Ingelheim Investigational Site 271

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Tulcea, Romania

Boehringer Ingelheim Investigational Site 272

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Turda, Romania

Boehringer Ingelheim Investigational Site 273

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Turnu Magurele, Romania

Boehringer Ingelheim Investigational Site 274

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Zalau, Romania

Boehringer Ingelheim Investigational Site 276

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Belgrade, Serbia

Boehringer Ingelheim Investigational Site 281

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Kraljevo, Serbia

Boehringer Ingelheim Investigational Site 279

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Nis, Serbia

Boehringer Ingelheim Investigational Site 122

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Banská Bystrica, Slovakia

Boehringer Ingelheim Investigational Site 126

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 133

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Brezno, Slovakia

Boehringer Ingelheim Investigational Site 137

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Hlohovec, Slovakia

Boehringer Ingelheim Investigational Site 158

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 144

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 145

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 150

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 152

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 153

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Martin, Slovakia

Boehringer Ingelheim Investigational Site 154

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Martin, Slovakia

Boehringer Ingelheim Investigational Site 178

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Vranov nad Top?ou, Slovakia

Boehringer Ingelheim Investigational Site 16

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Graz, Austria

Boehringer Ingelheim Investigational Site 95

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Wien, Austria

Boehringer Ingelheim Investigational Site 121

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Kuressaare, Estonia

Boehringer Ingelheim Investigational Site 93

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Wien, Austria

Boehringer Ingelheim Investigational Site 96

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Wien, Austria

Boehringer Ingelheim Investigational Site 98

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Wien, Austria

Boehringer Ingelheim Investigational Site 114

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Kohtla-Järve, Estonia

Boehringer Ingelheim Investigational Site 112

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Tallinn, Estonia

Boehringer Ingelheim Investigational Site 202

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 237

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Iasi, Romania

Boehringer Ingelheim Investigational Site 245

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Pitesti, Romania

Boehringer Ingelheim Investigational Site 249

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Radauti, Romania

Boehringer Ingelheim Investigational Site 260

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Targoviste, Romania

Boehringer Ingelheim Investigational Site 280

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Uzice, Serbia

Boehringer Ingelheim Investigational Site 149

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Liptovský Mikulás, Slovakia

Boehringer Ingelheim Investigational Site 148

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Krompachy, Slovakia

Boehringer Ingelheim Investigational Site 172

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Topolcany, Slovakia

Boehringer Ingelheim Investigational Site 169

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Skalica, Slovakia

Boehringer Ingelheim Investigational Site 170

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Stará Lubovna, Slovakia

Boehringer Ingelheim Investigational Site 174

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Trencín, Slovakia

Boehringer Ingelheim Investigational Site 180

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Zilina, Slovakia

Boehringer Ingelheim Investigational Site 31

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Innsbruck, Austria

Boehringer Ingelheim Investigational Site 1

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Bad Ischl, Austria

Boehringer Ingelheim Investigational Site 5

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Bludenz, Austria

Boehringer Ingelheim Investigational Site 6

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Braunau/Inn, Austria

Boehringer Ingelheim Investigational Site 3

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Baden, Austria

Boehringer Ingelheim Investigational Site 4

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Baden, Austria

Boehringer Ingelheim Investigational Site 9

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Dornbirn, Austria

Boehringer Ingelheim Investigational Site 13

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Feldbach, Austria

Boehringer Ingelheim Investigational Site 14

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Feldkirchen, Austria

Boehringer Ingelheim Investigational Site 18

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Graz, Austria

Boehringer Ingelheim Investigational Site 22

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Hainburg, Austria

Boehringer Ingelheim Investigational Site 26

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Hermagor, Austria

Boehringer Ingelheim Investigational Site 23

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Hall/Tirol, Austria

Boehringer Ingelheim Investigational Site 24

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Hallein, Austria

Boehringer Ingelheim Investigational Site 28

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Horn, Austria

Boehringer Ingelheim Investigational Site 29

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Horn, Austria

Boehringer Ingelheim Investigational Site 30

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Imst, Austria

Boehringer Ingelheim Investigational Site 32

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Innsbruck, Austria

Boehringer Ingelheim Investigational Site 34

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Judenburg, Austria

Boehringer Ingelheim Investigational Site 33

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Innsbruck, Austria

Boehringer Ingelheim Investigational Site 35

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Kapfenberg, Austria

Boehringer Ingelheim Investigational Site 36

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Klagenfurt, Austria

Boehringer Ingelheim Investigational Site 37

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Klagenfurt, Austria

Boehringer Ingelheim Investigational Site 38

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Klagenfurt, Austria

Boehringer Ingelheim Investigational Site 39

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Klagenfurt, Austria

Boehringer Ingelheim Investigational Site 41

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Krems, Austria

Boehringer Ingelheim Investigational Site 40

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Knittelfeld, Austria

Boehringer Ingelheim Investigational Site 44

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Leibnitz, Austria

Boehringer Ingelheim Investigational Site 45

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Leoben, Austria

Boehringer Ingelheim Investigational Site 46

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Lienz, Austria

Boehringer Ingelheim Investigational Site 47

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Lienz, Austria

Boehringer Ingelheim Investigational Site 48

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Lilienfeld, Austria

Boehringer Ingelheim Investigational Site 49

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Linz, Austria

Boehringer Ingelheim Investigational Site 50

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Linz, Austria

Boehringer Ingelheim Investigational Site 51

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Melk, Austria

Boehringer Ingelheim Investigational Site 52

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Mürzzuschlag, Austria

Boehringer Ingelheim Investigational Site 53

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Neulengbach, Austria

Boehringer Ingelheim Investigational Site 54

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Neulengbach, Austria

Boehringer Ingelheim Investigational Site 56

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Neunkirchen, Austria

Boehringer Ingelheim Investigational Site 55

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Neunkirchen, Austria

Boehringer Ingelheim Investigational Site 57

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Neusiedl am See, Austria

Boehringer Ingelheim Investigational Site 59

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Oberwart, Austria

Boehringer Ingelheim Investigational Site 58

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Oberwart, Austria

Boehringer Ingelheim Investigational Site 60

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Oberwart, Austria

Boehringer Ingelheim Investigational Site 63

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Ried im Innkreis, Austria

Boehringer Ingelheim Investigational Site 62

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Ried im Innkreis, Austria

Boehringer Ingelheim Investigational Site 61

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Regelsbrunn, Austria

Boehringer Ingelheim Investigational Site 64

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Rohrbach, Austria

Boehringer Ingelheim Investigational Site 65

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Salzburg, Austria

Boehringer Ingelheim Investigational Site 66

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Salzburg, Austria

Boehringer Ingelheim Investigational Site 69

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Scheibbs, Austria

Boehringer Ingelheim Investigational Site 68

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Salzburg, Austria

Boehringer Ingelheim Investigational Site 71

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St. Pölten, Austria

Boehringer Ingelheim Investigational Site 70

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St. Johann im Pongau, Austria

Boehringer Ingelheim Investigational Site 74

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Telfs, Austria

Boehringer Ingelheim Investigational Site 73

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St. Veit an der Glan, Austria

Boehringer Ingelheim Investigational Site 77

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Villach, Austria

Boehringer Ingelheim Investigational Site 75

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Tulln, Austria

Boehringer Ingelheim Investigational Site 79

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Villach-Warmbad, Austria

Boehringer Ingelheim Investigational Site 80

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Vöcklabruck, Austria

Boehringer Ingelheim Investigational Site 82

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Völkermarkt, Austria

Boehringer Ingelheim Investigational Site 108

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Wiener Neustadt, Austria

Boehringer Ingelheim Investigational Site 102

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Wien, Austria

Boehringer Ingelheim Investigational Site 105

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Wien, Austria

Boehringer Ingelheim Investigational Site 83

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Wagna, Austria

Boehringer Ingelheim Investigational Site 101

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Wien, Austria

Boehringer Ingelheim Investigational Site 103

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Wien, Austria

Boehringer Ingelheim Investigational Site 106

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Wien, Austria

Boehringer Ingelheim Investigational Site 107

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Wien, Austria

Boehringer Ingelheim Investigational Site 85

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Wien, Austria

Boehringer Ingelheim Investigational Site 86

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Wien, Austria

Boehringer Ingelheim Investigational Site 84

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Wien, Austria

Boehringer Ingelheim Investigational Site 88

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Wien, Austria

Boehringer Ingelheim Investigational Site 89

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Wien, Austria

Boehringer Ingelheim Investigational Site 91

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Wien, Austria

Boehringer Ingelheim Investigational Site 90

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Wien, Austria

Boehringer Ingelheim Investigational Site 92

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Wien, Austria

Boehringer Ingelheim Investigational Site 109

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Wolfsberg, Austria

Boehringer Ingelheim Investigational Site 119

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Viimsi, Estonia

Boehringer Ingelheim Investigational Site 284

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Astana, Kazakhstan

Boehringer Ingelheim Investigational Site 193

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Alba Iulia, Romania

Boehringer Ingelheim Investigational Site 282

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Shymkent, Kazakhstan

Boehringer Ingelheim Investigational Site 212

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 213

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 215

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 224

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Cluj-Napoca, Romania

Boehringer Ingelheim Investigational Site 228

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Craiova, Romania

Boehringer Ingelheim Investigational Site 227

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Constanta, Romania

Boehringer Ingelheim Investigational Site 233

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Curtea de Arges, Romania

Boehringer Ingelheim Investigational Site 235

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Focsani, Romania

Boehringer Ingelheim Investigational Site 236

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Galati, Romania

Boehringer Ingelheim Investigational Site 240

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Medgidia, Romania

Boehringer Ingelheim Investigational Site 246

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Pitesti, Romania

Boehringer Ingelheim Investigational Site 248

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Prahova, Romania

Boehringer Ingelheim Investigational Site 254

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Satu Mare, Romania

Boehringer Ingelheim Investigational Site 253

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Satu Mare, Romania

Boehringer Ingelheim Investigational Site 262

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Targu Mures, Romania

Boehringer Ingelheim Investigational Site 267

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Timisoara, Romania

Boehringer Ingelheim Investigational Site 264

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Tarnaveni, Romania

Boehringer Ingelheim Investigational Site 263

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Tarnaveni, Romania

Boehringer Ingelheim Investigational Site 265

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Timisoara, Romania

Boehringer Ingelheim Investigational Site 268

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Timisoara, Romania

Boehringer Ingelheim Investigational Site 275

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Belgrade, Serbia

Boehringer Ingelheim Investigational Site 278

🇷🇸

Kragujevac, Serbia

Boehringer Ingelheim Investigational Site 277

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Novi Sad, Serbia

Boehringer Ingelheim Investigational Site 123

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Bardejov, Slovakia

Boehringer Ingelheim Investigational Site 124

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Bardejov, Slovakia

Boehringer Ingelheim Investigational Site 125

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 127

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 128

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 130

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 129

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 131

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 132

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Bratislava, Slovakia

Boehringer Ingelheim Investigational Site 134

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Detva, Slovakia

Boehringer Ingelheim Investigational Site 135

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Dolný Kubín, Slovakia

Boehringer Ingelheim Investigational Site 136

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Dolný Kubín, Slovakia

Boehringer Ingelheim Investigational Site 139

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Humenné, Slovakia

Boehringer Ingelheim Investigational Site 138

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Hlohovec, Slovakia

Boehringer Ingelheim Investigational Site 141

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Kezmarok, Slovakia

Boehringer Ingelheim Investigational Site 142

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Komárno, Slovakia

Boehringer Ingelheim Investigational Site 140

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Kezmarok, Slovakia

Boehringer Ingelheim Investigational Site 143

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 146

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 147

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Kosice, Slovakia

Boehringer Ingelheim Investigational Site 151

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Lucenec, Slovakia

Boehringer Ingelheim Investigational Site 155

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Myjava, Slovakia

Boehringer Ingelheim Investigational Site 157

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 159

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 160

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Nitra, Slovakia

Boehringer Ingelheim Investigational Site 156

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Námestovo, Slovakia

Boehringer Ingelheim Investigational Site 161

🇸🇰

Pezinok, Slovakia

Boehringer Ingelheim Investigational Site 162

🇸🇰

Piestany, Slovakia

Boehringer Ingelheim Investigational Site 164

🇸🇰

Presov, Slovakia

Boehringer Ingelheim Investigational Site 165

🇸🇰

Presov, Slovakia

Boehringer Ingelheim Investigational Site 163

🇸🇰

Presov, Slovakia

Boehringer Ingelheim Investigational Site 167

🇸🇰

Sahy, Slovakia

Boehringer Ingelheim Investigational Site 166

🇸🇰

Presov, Slovakia

Boehringer Ingelheim Investigational Site 168

🇸🇰

Sala, Slovakia

Boehringer Ingelheim Investigational Site 171

🇸🇰

Surany, Slovakia

Boehringer Ingelheim Investigational Site 173

🇸🇰

Trebisov, Slovakia

Boehringer Ingelheim Investigational Site 175

🇸🇰

Trnava, Slovakia

Boehringer Ingelheim Investigational Site 176

🇸🇰

Trnava, Slovakia

Boehringer Ingelheim Investigational Site 179

🇸🇰

Ziar nad Hronom, Slovakia

Boehringer Ingelheim Investigational Site 177

🇸🇰

Trstená, Slovakia

Boehringer Ingelheim Investigational Site 181

🇸🇰

Zvolen, Slovakia

Boehringer Ingelheim Investigational Site 182

🇸🇰

Zlaté Moravce, Slovakia

Boehringer Ingelheim Investigational Site 183

🇸🇮

Celje, Slovenia

Boehringer Ingelheim Investigational Site 184

🇸🇮

Lesce, Slovenia

Boehringer Ingelheim Investigational Site 186

🇸🇮

Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 185

🇸🇮

Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 188

🇸🇮

Maribor, Slovenia

Boehringer Ingelheim Investigational Site 187

🇸🇮

Maribor, Slovenia

Boehringer Ingelheim Investigational Site 190

🇸🇮

Sempeter, Slovenia

Boehringer Ingelheim Investigational Site 191

🇸🇮

Sempeter, Slovenia

Boehringer Ingelheim Investigational Site 189

🇸🇮

Slovenj Gradec, Slovenia

Boehringer Ingelheim Investigational Site 192

🇸🇮

Velenje, Slovenia

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