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NCT01061567 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01061567
Other study ID # 248.675
Secondary ID
Status Completed
Phase N/A
First received December 24, 2009
Last updated June 6, 2014
Start date November 2009
Est. completion date June 2013

Study information
Verified date June 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Austria: Medicines and Medical Devices AgencyEstonia: The State Agency of MedicineKazakhstan: Ethical CommissionRomania: Ministry of Public HealthSerbia: Ethics CommitteeSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1814
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Early and advanced idiopathic Parkinson's disease

- Male and female patients over 18 years of age

- Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Exclusion criteria:

- Ongoing treatment with pramipexole ER

- Exclusion criteria in line with the pramipexole ER SmPC:

In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Boehringer Ingelheim Investigational Site 1 Bad Ischl
Austria Boehringer Ingelheim Investigational Site 2 Bad Radkersburg
Austria Boehringer Ingelheim Investigational Site 3 Baden
Austria Boehringer Ingelheim Investigational Site 4 Baden
Austria Boehringer Ingelheim Investigational Site 5 Bludenz
Austria Boehringer Ingelheim Investigational Site 6 Braunau/Inn
Austria Boehringer Ingelheim Investigational Site 7 Deutschlandsberg
Austria Boehringer Ingelheim Investigational Site 8 Dornbirn
Austria Boehringer Ingelheim Investigational Site 9 Dornbirn
Austria Boehringer Ingelheim Investigational Site 10 Ehenbichl
Austria Boehringer Ingelheim Investigational Site 11 Eisenstadt
Austria Boehringer Ingelheim Investigational Site 12 Eisenstadt
Austria Boehringer Ingelheim Investigational Site 13 Feldbach
Austria Boehringer Ingelheim Investigational Site 14 Feldkirchen
Austria Boehringer Ingelheim Investigational Site 15 Gänserndorf
Austria Boehringer Ingelheim Investigational Site 16 Graz
Austria Boehringer Ingelheim Investigational Site 17 Graz
Austria Boehringer Ingelheim Investigational Site 18 Graz
Austria Boehringer Ingelheim Investigational Site 19 Graz
Austria Boehringer Ingelheim Investigational Site 20 Grieskirchen
Austria Boehringer Ingelheim Investigational Site 21 Grimmenstein
Austria Boehringer Ingelheim Investigational Site 22 Hainburg
Austria Boehringer Ingelheim Investigational Site 23 Hall/Tirol
Austria Boehringer Ingelheim Investigational Site 24 Hallein
Austria Boehringer Ingelheim Investigational Site 25 Hartberg
Austria Boehringer Ingelheim Investigational Site 26 Hermagor
Austria Boehringer Ingelheim Investigational Site 27 Hohenems
Austria Boehringer Ingelheim Investigational Site 28 Horn
Austria Boehringer Ingelheim Investigational Site 29 Horn
Austria Boehringer Ingelheim Investigational Site 30 Imst
Austria Boehringer Ingelheim Investigational Site 31 Innsbruck
Austria Boehringer Ingelheim Investigational Site 32 Innsbruck
Austria Boehringer Ingelheim Investigational Site 33 Innsbruck
Austria Boehringer Ingelheim Investigational Site 34 Judenburg
Austria Boehringer Ingelheim Investigational Site 35 Kapfenberg
Austria Boehringer Ingelheim Investigational Site 36 Klagenfurt
Austria Boehringer Ingelheim Investigational Site 37 Klagenfurt
Austria Boehringer Ingelheim Investigational Site 38 Klagenfurt
Austria Boehringer Ingelheim Investigational Site 39 Klagenfurt
Austria Boehringer Ingelheim Investigational Site 40 Knittelfeld
Austria Boehringer Ingelheim Investigational Site 41 Krems
Austria Boehringer Ingelheim Investigational Site 42 Kufstein
Austria Boehringer Ingelheim Investigational Site 43 Laßnitzhöhe
Austria Boehringer Ingelheim Investigational Site 44 Leibnitz
Austria Boehringer Ingelheim Investigational Site 45 Leoben
Austria Boehringer Ingelheim Investigational Site 46 Lienz
Austria Boehringer Ingelheim Investigational Site 47 Lienz
Austria Boehringer Ingelheim Investigational Site 48 Lilienfeld
Austria Boehringer Ingelheim Investigational Site 49 Linz
Austria Boehringer Ingelheim Investigational Site 50 Linz
Austria Boehringer Ingelheim Investigational Site 51 Melk
Austria Boehringer Ingelheim Investigational Site 52 Mürzzuschlag
Austria Boehringer Ingelheim Investigational Site 53 Neulengbach
Austria Boehringer Ingelheim Investigational Site 54 Neulengbach
Austria Boehringer Ingelheim Investigational Site 55 Neunkirchen
Austria Boehringer Ingelheim Investigational Site 56 Neunkirchen
Austria Boehringer Ingelheim Investigational Site 57 Neusiedl am See
Austria Boehringer Ingelheim Investigational Site 58 Oberwart
Austria Boehringer Ingelheim Investigational Site 59 Oberwart
Austria Boehringer Ingelheim Investigational Site 60 Oberwart
Austria Boehringer Ingelheim Investigational Site 61 Regelsbrunn
Austria Boehringer Ingelheim Investigational Site 62 Ried im Innkreis
Austria Boehringer Ingelheim Investigational Site 63 Ried im Innkreis
Austria Boehringer Ingelheim Investigational Site 64 Rohrbach
Austria Boehringer Ingelheim Investigational Site 65 Salzburg
Austria Boehringer Ingelheim Investigational Site 66 Salzburg
Austria Boehringer Ingelheim Investigational Site 67 Salzburg
Austria Boehringer Ingelheim Investigational Site 68 Salzburg
Austria Boehringer Ingelheim Investigational Site 69 Scheibbs
Austria Boehringer Ingelheim Investigational Site 70 St. Johann im Pongau
Austria Boehringer Ingelheim Investigational Site 71 St. Pölten
Austria Boehringer Ingelheim Investigational Site 72 St. Pölten
Austria Boehringer Ingelheim Investigational Site 73 St. Veit an der Glan
Austria Boehringer Ingelheim Investigational Site 74 Telfs
Austria Boehringer Ingelheim Investigational Site 75 Tulln
Austria Boehringer Ingelheim Investigational Site 76 Tullnerbach-Lawies
Austria Boehringer Ingelheim Investigational Site 77 Villach
Austria Boehringer Ingelheim Investigational Site 78 Villach
Austria Boehringer Ingelheim Investigational Site 79 Villach-Warmbad
Austria Boehringer Ingelheim Investigational Site 80 Vöcklabruck
Austria Boehringer Ingelheim Investigational Site 81 Vöcklabruck
Austria Boehringer Ingelheim Investigational Site 82 Völkermarkt
Austria Boehringer Ingelheim Investigational Site 83 Wagna
Austria Boehringer Ingelheim Investigational Site 100 Wien
Austria Boehringer Ingelheim Investigational Site 101 Wien
Austria Boehringer Ingelheim Investigational Site 102 Wien
Austria Boehringer Ingelheim Investigational Site 103 Wien
Austria Boehringer Ingelheim Investigational Site 104 Wien
Austria Boehringer Ingelheim Investigational Site 105 Wien
Austria Boehringer Ingelheim Investigational Site 106 Wien
Austria Boehringer Ingelheim Investigational Site 107 Wien
Austria Boehringer Ingelheim Investigational Site 84 Wien
Austria Boehringer Ingelheim Investigational Site 85 Wien
Austria Boehringer Ingelheim Investigational Site 86 Wien
Austria Boehringer Ingelheim Investigational Site 87 Wien
Austria Boehringer Ingelheim Investigational Site 88 Wien
Austria Boehringer Ingelheim Investigational Site 89 Wien
Austria Boehringer Ingelheim Investigational Site 90 Wien
Austria Boehringer Ingelheim Investigational Site 91 Wien
Austria Boehringer Ingelheim Investigational Site 92 Wien
Austria Boehringer Ingelheim Investigational Site 93 Wien
Austria Boehringer Ingelheim Investigational Site 94 Wien
Austria Boehringer Ingelheim Investigational Site 95 Wien
Austria Boehringer Ingelheim Investigational Site 96 Wien
Austria Boehringer Ingelheim Investigational Site 97 Wien
Austria Boehringer Ingelheim Investigational Site 98 Wien
Austria Boehringer Ingelheim Investigational Site 99 Wien
Austria Boehringer Ingelheim Investigational Site 108 Wiener Neustadt
Austria Boehringer Ingelheim Investigational Site 109 Wolfsberg
Austria Boehringer Ingelheim Investigational Site 110 Zirl
Austria Boehringer Ingelheim Investigational Site 111 Zwettl
Estonia Boehringer Ingelheim Investigational Site 115 Järvamaa
Estonia Boehringer Ingelheim Investigational Site 114 Kohtla-Järve
Estonia Boehringer Ingelheim Investigational Site 121 Kuressaare
Estonia Boehringer Ingelheim Investigational Site 116 Rakvere
Estonia Boehringer Ingelheim Investigational Site 112 Tallinn
Estonia Boehringer Ingelheim Investigational Site 113 Tallinn
Estonia Boehringer Ingelheim Investigational Site 117 Tartu
Estonia Boehringer Ingelheim Investigational Site 118 Valga
Estonia Boehringer Ingelheim Investigational Site 119 Viimsi
Estonia Boehringer Ingelheim Investigational Site 120 Viljandi
Kazakhstan Boehringer Ingelheim Investigational Site 283 Almaty
Kazakhstan Boehringer Ingelheim Investigational Site 284 Astana
Kazakhstan Boehringer Ingelheim Investigational Site 282 Shymkent
Romania Boehringer Ingelheim Investigational Site 193 Alba Iulia
Romania Boehringer Ingelheim Investigational Site 194 Bacau
Romania Boehringer Ingelheim Investigational Site 195 Bacau
Romania Boehringer Ingelheim Investigational Site 196 Bacau
Romania Boehringer Ingelheim Investigational Site 197 Baia Mare
Romania Boehringer Ingelheim Investigational Site 198 Baia Mare
Romania Boehringer Ingelheim Investigational Site 199 Botosani
Romania Boehringer Ingelheim Investigational Site 200 Brasov
Romania Boehringer Ingelheim Investigational Site 201 Brasov
Romania Boehringer Ingelheim Investigational Site 202 Bucuresti
Romania Boehringer Ingelheim Investigational Site 203 Bucuresti
Romania Boehringer Ingelheim Investigational Site 204 Bucuresti
Romania Boehringer Ingelheim Investigational Site 205 Bucuresti
Romania Boehringer Ingelheim Investigational Site 206 Bucuresti
Romania Boehringer Ingelheim Investigational Site 207 Bucuresti
Romania Boehringer Ingelheim Investigational Site 208 Bucuresti
Romania Boehringer Ingelheim Investigational Site 209 Bucuresti
Romania Boehringer Ingelheim Investigational Site 210 Bucuresti
Romania Boehringer Ingelheim Investigational Site 211 Bucuresti
Romania Boehringer Ingelheim Investigational Site 212 Bucuresti
Romania Boehringer Ingelheim Investigational Site 213 Bucuresti
Romania Boehringer Ingelheim Investigational Site 214 Bucuresti
Romania Boehringer Ingelheim Investigational Site 215 Bucuresti
Romania Boehringer Ingelheim Investigational Site 216 Bucuresti
Romania Boehringer Ingelheim Investigational Site 217 Bucuresti
Romania Boehringer Ingelheim Investigational Site 218 Bucuresti
Romania Boehringer Ingelheim Investigational Site 219 Bucuresti
Romania Boehringer Ingelheim Investigational Site 220 Buzau
Romania Boehringer Ingelheim Investigational Site 221 Buzau
Romania Boehringer Ingelheim Investigational Site 222 Campulung
Romania Boehringer Ingelheim Investigational Site 223 Cluj-Napoca
Romania Boehringer Ingelheim Investigational Site 224 Cluj-Napoca
Romania Boehringer Ingelheim Investigational Site 225 Constanta
Romania Boehringer Ingelheim Investigational Site 226 Constanta
Romania Boehringer Ingelheim Investigational Site 227 Constanta
Romania Boehringer Ingelheim Investigational Site 228 Craiova
Romania Boehringer Ingelheim Investigational Site 229 Craiova
Romania Boehringer Ingelheim Investigational Site 230 Craiova
Romania Boehringer Ingelheim Investigational Site 231 Craiova
Romania Boehringer Ingelheim Investigational Site 232 Craiova
Romania Boehringer Ingelheim Investigational Site 233 Curtea de Arges
Romania Boehringer Ingelheim Investigational Site 234 Focsani
Romania Boehringer Ingelheim Investigational Site 235 Focsani
Romania Boehringer Ingelheim Investigational Site 236 Galati
Romania Boehringer Ingelheim Investigational Site 237 Iasi
Romania Boehringer Ingelheim Investigational Site 238 Iasi
Romania Boehringer Ingelheim Investigational Site 239 Iasi
Romania Boehringer Ingelheim Investigational Site 240 Medgidia
Romania Boehringer Ingelheim Investigational Site 241 Oradea
Romania Boehringer Ingelheim Investigational Site 242 Oradea
Romania Boehringer Ingelheim Investigational Site 243 Piatra Neamt
Romania Boehringer Ingelheim Investigational Site 244 Piatra Neamt
Romania Boehringer Ingelheim Investigational Site 245 Pitesti
Romania Boehringer Ingelheim Investigational Site 246 Pitesti
Romania Boehringer Ingelheim Investigational Site 247 Ploiesti
Romania Boehringer Ingelheim Investigational Site 248 Prahova
Romania Boehringer Ingelheim Investigational Site 249 Radauti
Romania Boehringer Ingelheim Investigational Site 250 Ramnicu Valcea
Romania Boehringer Ingelheim Investigational Site 251 Ramnicu Valcea
Romania Boehringer Ingelheim Investigational Site 252 Ramnicu Valcea
Romania Boehringer Ingelheim Investigational Site 253 Satu Mare
Romania Boehringer Ingelheim Investigational Site 254 Satu Mare
Romania Boehringer Ingelheim Investigational Site 255 Sibiu
Romania Boehringer Ingelheim Investigational Site 256 Sibiu
Romania Boehringer Ingelheim Investigational Site 257 Simleul Silvaniei
Romania Boehringer Ingelheim Investigational Site 258 Slobozia
Romania Boehringer Ingelheim Investigational Site 259 Suceava
Romania Boehringer Ingelheim Investigational Site 260 Targoviste
Romania Boehringer Ingelheim Investigational Site 261 Targoviste
Romania Boehringer Ingelheim Investigational Site 262 Targu Mures
Romania Boehringer Ingelheim Investigational Site 263 Tarnaveni
Romania Boehringer Ingelheim Investigational Site 264 Tarnaveni
Romania Boehringer Ingelheim Investigational Site 265 Timisoara
Romania Boehringer Ingelheim Investigational Site 266 Timisoara
Romania Boehringer Ingelheim Investigational Site 267 Timisoara
Romania Boehringer Ingelheim Investigational Site 268 Timisoara
Romania Boehringer Ingelheim Investigational Site 269 Tulcea
Romania Boehringer Ingelheim Investigational Site 270 Tulcea
Romania Boehringer Ingelheim Investigational Site 271 Tulcea
Romania Boehringer Ingelheim Investigational Site 272 Turda
Romania Boehringer Ingelheim Investigational Site 273 Turnu Magurele
Romania Boehringer Ingelheim Investigational Site 274 Zalau
Serbia Boehringer Ingelheim Investigational Site 275 Belgrade
Serbia Boehringer Ingelheim Investigational Site 276 Belgrade
Serbia Boehringer Ingelheim Investigational Site 278 Kragujevac
Serbia Boehringer Ingelheim Investigational Site 281 Kraljevo
Serbia Boehringer Ingelheim Investigational Site 279 Nis
Serbia Boehringer Ingelheim Investigational Site 277 Novi Sad
Serbia Boehringer Ingelheim Investigational Site 280 Uzice
Slovakia Boehringer Ingelheim Investigational Site 122 Banská Bystrica
Slovakia Boehringer Ingelheim Investigational Site 123 Bardejov
Slovakia Boehringer Ingelheim Investigational Site 124 Bardejov
Slovakia Boehringer Ingelheim Investigational Site 125 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 126 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 127 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 128 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 129 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 130 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 131 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 132 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 133 Brezno
Slovakia Boehringer Ingelheim Investigational Site 134 Detva
Slovakia Boehringer Ingelheim Investigational Site 135 Dolný Kubín
Slovakia Boehringer Ingelheim Investigational Site 136 Dolný Kubín
Slovakia Boehringer Ingelheim Investigational Site 137 Hlohovec
Slovakia Boehringer Ingelheim Investigational Site 138 Hlohovec
Slovakia Boehringer Ingelheim Investigational Site 139 Humenné
Slovakia Boehringer Ingelheim Investigational Site 140 Kezmarok
Slovakia Boehringer Ingelheim Investigational Site 141 Kezmarok
Slovakia Boehringer Ingelheim Investigational Site 142 Komárno
Slovakia Boehringer Ingelheim Investigational Site 143 Kosice
Slovakia Boehringer Ingelheim Investigational Site 144 Kosice
Slovakia Boehringer Ingelheim Investigational Site 145 Kosice
Slovakia Boehringer Ingelheim Investigational Site 146 Kosice
Slovakia Boehringer Ingelheim Investigational Site 147 Kosice
Slovakia Boehringer Ingelheim Investigational Site 148 Krompachy
Slovakia Boehringer Ingelheim Investigational Site 149 Liptovský Mikulás
Slovakia Boehringer Ingelheim Investigational Site 150 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 151 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 152 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 153 Martin
Slovakia Boehringer Ingelheim Investigational Site 154 Martin
Slovakia Boehringer Ingelheim Investigational Site 155 Myjava
Slovakia Boehringer Ingelheim Investigational Site 156 Námestovo
Slovakia Boehringer Ingelheim Investigational Site 157 Nitra
Slovakia Boehringer Ingelheim Investigational Site 158 Nitra
Slovakia Boehringer Ingelheim Investigational Site 159 Nitra
Slovakia Boehringer Ingelheim Investigational Site 160 Nitra
Slovakia Boehringer Ingelheim Investigational Site 161 Pezinok
Slovakia Boehringer Ingelheim Investigational Site 162 Piestany
Slovakia Boehringer Ingelheim Investigational Site 163 Presov
Slovakia Boehringer Ingelheim Investigational Site 164 Presov
Slovakia Boehringer Ingelheim Investigational Site 165 Presov
Slovakia Boehringer Ingelheim Investigational Site 166 Presov
Slovakia Boehringer Ingelheim Investigational Site 167 Sahy
Slovakia Boehringer Ingelheim Investigational Site 168 Sala
Slovakia Boehringer Ingelheim Investigational Site 169 Skalica
Slovakia Boehringer Ingelheim Investigational Site 170 Stará Lubovna
Slovakia Boehringer Ingelheim Investigational Site 171 Surany
Slovakia Boehringer Ingelheim Investigational Site 172 Topolcany
Slovakia Boehringer Ingelheim Investigational Site 173 Trebisov
Slovakia Boehringer Ingelheim Investigational Site 174 Trencín
Slovakia Boehringer Ingelheim Investigational Site 175 Trnava
Slovakia Boehringer Ingelheim Investigational Site 176 Trnava
Slovakia Boehringer Ingelheim Investigational Site 177 Trstená
Slovakia Boehringer Ingelheim Investigational Site 178 Vranov nad Top?ou
Slovakia Boehringer Ingelheim Investigational Site 179 Ziar nad Hronom
Slovakia Boehringer Ingelheim Investigational Site 180 Zilina
Slovakia Boehringer Ingelheim Investigational Site 182 Zlaté Moravce
Slovakia Boehringer Ingelheim Investigational Site 181 Zvolen
Slovenia Boehringer Ingelheim Investigational Site 183 Celje
Slovenia Boehringer Ingelheim Investigational Site 184 Lesce
Slovenia Boehringer Ingelheim Investigational Site 185 Ljubljana
Slovenia Boehringer Ingelheim Investigational Site 186 Ljubljana
Slovenia Boehringer Ingelheim Investigational Site 187 Maribor
Slovenia Boehringer Ingelheim Investigational Site 188 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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Estonia,  Kazakhstan,  Romania,  Serbia,  Slovakia,  Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events The number of patients with any adverse events (AEs), patients with drug-related AEs. From the treatment initiation to the end of study, on average 92.9 days No
Primary Proportion of Patients With Withdrawals Due to Adverse Events. Patients who discontinued treatment due to adverse events including deaths. 16 weeks No
Secondary Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score 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. Baseline and the end of study (up to 16 weeks) No
Secondary Clinical Global Impression of Improvement (CGI-I) Responder Rate 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. Baseline and the end of study (up to 16 weeks) No
Secondary Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction 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. Baseline and the end of study (up to 16 weeks) No
Secondary Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score 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 Baseline and the end of study (up to 16 weeks) No
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