Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder | NCT00689104 | Trialant

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder | NCT00689104 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly

Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months

Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period

Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion Criteria:

Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control

Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor

Subject has an indwelling catheter or practices intermittent self-catheterization

Subject has diabetic neuropathy

Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

Subject receives non-drug treatment including electro-stimulation therapy

Subject has severe hypertension

Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients

Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)

Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period

Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN

Subject has a clinically significant abnormal electrocardiogram (ECG)

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Auchenflower, Australia

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Clayton, Australia

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Kogarah, Australia

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Randwick, Australia

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Woolloongabba, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4020, Austria

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Minsk, 220036, Belarus

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Minsk, 220119, Belarus

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Minsk, 223041, Belarus

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Antwerp, 2020, Belgium

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Antwerp, 2030, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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Leper, 8900, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Sint-Truiden, 3800, Belgium

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Pleven, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Brno, 60200, Czechia

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Mělník, 27601, Czechia

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Olomouc, 77200, Czechia

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Ostrava-Poruba, 70853, Czechia

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Pilsen, 30599, Czechia

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Prague, 12851, Czechia

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Prague, 14056, Czechia

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Prague, 18081, Czechia

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Štětí, 41108, Czechia

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Ústí nad Labem, 40001, Czechia

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Aalborg, 9100, Denmark

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Aarhus, 8200, Denmark

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Glostrup Municipality, 2600, Denmark

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Roskilde, Denmark

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Helsinki, 00029, Finland

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Oulu, 90220, Finland

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Tampere, 33521, Finland

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Turku, 20100, Finland

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Bordeaux, 33076, France

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Colmar, 68024, France

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Marseille, 13274, France

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Marseille, 13285, France

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Mulhouse, 68070, France

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Nantes, 45035, France

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Nîmes, 30029, France

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Orléans, 45067, France

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Paris, 75020, France

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Paris, 75571, France

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Rouen, 76031, France

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Saint-Priest-en-Jarez, 42055, France

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Strasbourg, 67000, France

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Toulouse, 31059, France

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Aichach, 86551, Germany

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Bad Ems, 56130, Germany

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Bautzen, 02625, Germany

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Berlin, 13347, Germany

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Duisburg, 47051, Germany

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Eisleben Lutherstadt, 06295, Germany

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Frankfurt, 65933, Germany

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Ganderkesee, 27777, Germany

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Hagenow, 19230, Germany

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Halle, 06132, Germany

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Hamburg, 20253, Germany

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Henningsdorf, 16761, Germany

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Hettstedt, 06333, Germany

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Koblenz, 56068, Germany

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Leipzig, 04105, Germany

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Muenchen-Bogenhausen, 81925, Germany

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Neustadt in Sachsen, 01844, Germany

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Oranienburg, 16151, Germany

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Radebeul, 01445, Germany

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Sangerhausen, 06526, Germany

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Trier, 54290, Germany

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Uetersen, 25436, Germany

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Athens, Greece

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Nikaias-Piraeus, Greece

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Pátrai, Greece

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Thessaloniki, Greece

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Budapest, 1047, Hungary

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Budapest, 1076, Hungary

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Budapest, 1204, Hungary

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Debrecen, 4043, Hungary

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Eger, 3300, Hungary

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Nyíregyháza, 4400, Hungary

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Pápa, Hungary

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Sopron, Hungary

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Szeged, 6725, Hungary

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Reykjavik, 101, Iceland

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Cork, Ireland

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Dublin, Ireland

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Mullingar, Ireland

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Tralee, Ireland

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Bari, 70124, Italy

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Catanzaro, 88100, Italy

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Florence, 50139, Italy

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Latina, 04100, Italy

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Magenta, 20013, Italy

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Milan, 20142, Italy

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Milan, 20153, Italy

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Naples, 80131, Italy

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Perugia, 06122, Italy

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Teramo, 64100, Italy

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Liepāja, Latvia

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Riga, Latvia

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Kaunas, Lithuania

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Vilnius, Lithuania

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Amsterdam, 1105 AZ, Netherlands

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Apeldoorn, 7334 DZ, Netherlands

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Apeldoorn, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7511 JX, Netherlands

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Leiden, 2334 CK, Netherlands

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Maastricht, 6229 HX, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Sneek, 8600 BA, Netherlands

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Winterswijk, 7101 BN, Netherlands

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Bergen, 5021, Norway

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Drammen, 3016, Norway

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Hamar, 2317, Norway

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Oslo, 0257, Norway

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Tønsberg, 3103, Norway

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Bialystok, 15-278, Poland

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Chorzów, 41-500, Poland

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Lodz, 93-338, Poland

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Lodz, 93-513, Poland

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Lublin, 20-954, Poland

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Warsaw, 00-846, Poland

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Warsaw, 02-005, Poland

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Warsaw, 02-507, Poland

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Wroclaw, 50-556, Poland

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Tomar, 2304-909, Portugal

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Viana do Castelo, 4900-858, Portugal

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Bucharest, Romania

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Lasi, Romania

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Oradea, Romania

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Timișoara, Romania

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Moscow, 101000, Russia

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Moscow, 105425, Russia

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Moscow, 111020, Russia

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Moscow, 111123, Russia

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Moscow, 115516, Russia

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Moscow, 117049, Russia

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Moscow, 117815, Russia

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Moscow, 119435, Russia

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Moscow, 123836, Russia

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Moscow, 125206, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, 198013, Russia

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Martin, 03659, Slovakia

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Poprad, 05801, Slovakia

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Skalica, 90982, Slovakia

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Trenčín, 91101, Slovakia

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Žilina, 01207, Slovakia

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Bloemfontein, South Africa

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Hatfield, South Africa

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Lyttelton, South Africa

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Paarl, South Africa

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Pietermaritzburg, South Africa

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Barcelona, 08020, Spain

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Bilbao, 48013, Spain

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Esplugues de Llobregat-Barcelo, 08950, Spain

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Fuenlabrada, 28942, Spain

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Getafe, 28905, Spain

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Madrid, 28016, Spain

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Madrid, 28046, Spain

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Madrid, Spain

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Mataró, 8304, Spain

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Miranda de Ebro, 09200, Spain

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Palma de Mallorca, 07014, Spain

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Seville, 41013, Spain

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Toledo, 45071, Spain

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Valencia, 46010, Spain

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Villarreal de Huerva, 12540, Spain

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Borås, 50182, Sweden

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Helsingborg, 25187, Sweden

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Örebro, 70185, Sweden

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Skövde, 54130, Sweden

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Stockholm, 11883, Sweden

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Stockholm, 14186, Sweden

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Stockholm, 17176, Sweden

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Stockholm, 18288, Sweden

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Umeå, 90185, Sweden

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Uppsala, 75185, Sweden

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Frauenfeld, 8501, Switzerland

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Lucerne, 6000, Switzerland

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Kiev, 01023, Ukraine

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Kiev, 04053, Ukraine

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Chorley, PR7 7NA, United Kingdom

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Reading, RG2 7AG, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Swansea, SA6 6NL, United Kingdom