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Brief Title: Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Official Title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Study ID: NCT00694382
Brief Summary: The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.
Detailed Description: Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1). The study period per participant was variable depending on the duration of chemotherapy. It included: * a screening period up to 3 weeks, * a double-blind treatment period, * a follow-up period of 1 month. Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site Number 840006, Birmingham, Alabama, United States
Investigational Site Number 840007, Casa Grande, Arizona, United States
Investigational Site Number 840060, Tucson, Arizona, United States
Investigational Site Number 840050, Fountain Valley, California, United States
Investigational Site Number 840072, Fullerton, California, United States
Investigational Site Number 840037, Indian Wells, California, United States
Investigational Site Number 840069, La Verne, California, United States
Investigational Site Number 840009, Long Beach, California, United States
Investigational Site Number 840001, Oceanside, California, United States
Investigational Site Number 840011, Rancho Mirage, California, United States
Investigational Site Number 840029, West Covina, California, United States
Investigational Site Number 840005, Norwich, Connecticut, United States
Investigational Site Number 840064, Torrington, Connecticut, United States
Investigational Site Number 840038, Woodbridge, Connecticut, United States
Investigational Site Number 840052, Washington, District of Columbia, United States
Investigational Site Number 840025, Washington, District of Columbia, United States
Investigational Site Number 840074, Clearwater, Florida, United States
Investigational Site Number 840019, Jacksonville, Florida, United States
Investigational Site Number 840051, Rockledge, Florida, United States
Investigational Site Number 840073, Sarasota, Florida, United States
Investigational Site Number 840070, Roswell, Georgia, United States
Investigational Site Number 840016, Park Ridge, Illinois, United States
Investigational Site Number 840028, Quincy, Illinois, United States
Investigational Site Number 840008, Skokie, Illinois, United States
Investigational Site Number 840033, Goshen, Indiana, United States
Investigational Site Number 840010, Indianapolis, Indiana, United States
Investigational Site Number 840014, Louisville, Kentucky, United States
Investigational Site Number 840048, Mount Sterling, Kentucky, United States
Investigational Site Number 840047, Metairie, Louisiana, United States
Investigational Site Number 840032, Ruston, Louisiana, United States
Investigational Site Number 840042, Bethesda, Maryland, United States
Investigational Site Number 840066, Easton, Maryland, United States
Investigational Site Number 840059, Tupelo, Mississippi, United States
Investigational Site Number 840024, Rochester, New York, United States
Investigational Site Number 840031, Syracuse, New York, United States
Investigational Site Number 840020, Durham, North Carolina, United States
Investigational Site Number 840021, Durham, North Carolina, United States
Investigational Site Number 840026, High Point, North Carolina, United States
Investigational Site Number 840046, Bismarck, North Dakota, United States
Investigational Site Number 840003, Middletown, Ohio, United States
Investigational Site Number 840022, Sylvania, Ohio, United States
Investigational Site Number 840075, East Providence, Rhode Island, United States
Investigational Site Number 840067, Beaumont, Texas, United States
Investigational Site Number 840004, El Paso, Texas, United States
Investigational Site Number 840034, Houston, Texas, United States
Investigational Site Number 840035, Sugar Land, Texas, United States
Investigational Site Number 840063, Kennewick, Washington, United States
Investigational Site Number 840018, Tacoma, Washington, United States
Investigational Site Number 032006, Buenos Aires, , Argentina
Investigational Site Number 032003, Capital Federal, , Argentina
Investigational Site Number 032004, Rosario, , Argentina
Investigational Site Number 032005, San Miguel De Tucuman, , Argentina
Investigational Site Number 032007, Tucuman, , Argentina
Investigational Site Number 036004, Adelaide, , Australia
Investigational Site Number 036002, Bedford Park, , Australia
Investigational Site Number 036001, Box Hill, , Australia
Investigational Site Number 036009, Lismore, , Australia
Investigational Site Number 036007, Perth, , Australia
Investigational Site Number 036006, Ringwood East, , Australia
Investigational Site Number 036008, Westmead, , Australia
Investigational Site Number 036003, Woodville, , Australia
Investigational Site Number 036005, Woolloongabba, , Australia
Investigational Site Number 040002, Graz, , Austria
Investigational Site Number 040003, Wien, , Austria
Investigational Site Number 040004, Wien, , Austria
Investigational Site Number 112002, Gomel, , Belarus
Investigational Site Number 112003, Minsk, , Belarus
Investigational Site Number 112001, Minsk, , Belarus
Investigational Site Number 112004, Vitebsk, , Belarus
Investigational Site Number 056008, Bonheiden, , Belgium
Investigational Site Number 056011, Brussels, , Belgium
Investigational Site Number 056005, Gent, , Belgium
Investigational Site Number 056010, Haine-Saint-Paul, , Belgium
Investigational Site Number 056006, Kortrijk, , Belgium
Investigational Site Number 056009, Liège, , Belgium
Investigational Site Number 056004, Merksem, , Belgium
Investigational Site Number 056003, Oostende, , Belgium
Investigational Site Number 056012, Ottignies, , Belgium
Investigational Site Number 056002, Sint Niklaas, , Belgium
Investigational Site Number 076002, Belo Horizonte, , Brazil
Investigational Site Number 076022, Curitiba, , Brazil
Investigational Site Number 076015, Curitiba, , Brazil
Investigational Site Number 076012, Florianopolis, , Brazil
Investigational Site Number 076001, Fortaleza, , Brazil
Investigational Site Number 076009, Goiania, , Brazil
Investigational Site Number 076007, Goiania, , Brazil
Investigational Site Number 076016, Goiania, , Brazil
Investigational Site Number 076024, Ijui, , Brazil
Investigational Site Number 076003, Joinville, , Brazil
Investigational Site Number 076010, Londrina, , Brazil
Investigational Site Number 076026, Passo Fundo, , Brazil
Investigational Site Number 076027, Passo Fundo, , Brazil
Investigational Site Number 076023, Porto Alegre, , Brazil
Investigational Site Number 076020, Porto Alegre, , Brazil
Investigational Site Number 076014, Salvador, , Brazil
Investigational Site Number 076018, Salvador, , Brazil
Investigational Site Number 076011, Santo Andre, , Brazil
Investigational Site Number 076006, Sao Jose Dos Campos, , Brazil
Investigational Site Number 076008, Sao Paulo, , Brazil
Investigational Site Number 076017, Sao Paulo, , Brazil
Investigational Site Number 076004, Taguatinga, , Brazil
Investigational Site Number 100001, Rousse, , Bulgaria
Investigational Site Number 100003, Varna, , Bulgaria
Investigational Site Number 124008, Greenfield Park, , Canada
Investigational Site Number 124007, Kelowna, , Canada
Investigational Site Number 124010, Moncton, , Canada
Investigational Site Number 124003, Montreal, , Canada
Investigational Site Number 124002, Ottawa, , Canada
Investigational Site Number 124009, Owen Sound, , Canada
Investigational Site Number 124006, Rimouski, , Canada
Investigational Site Number 124013, Saint John, , Canada
Investigational Site Number 124001, Sherbrooke, , Canada
Investigational Site Number 124012, Victoria, , Canada
Investigational Site Number 124011, Weston, , Canada
Investigational Site Number 152002, Temuco, , Chile
Investigational Site Number 156014, Beijing, , China
Investigational Site Number 156008, Beijing, , China
Investigational Site Number 156022, Beijing, , China
Investigational Site Number 156031, Changchun, , China
Investigational Site Number 156021, Chengdu, , China
Investigational Site Number 156019, Chongqing, , China
Investigational Site Number 156003, Dalian, , China
Investigational Site Number 156025, Guangzhou, , China
Investigational Site Number 156026, Hangzhou, , China
Investigational Site Number 156030, Nanning, , China
Investigational Site Number 156029, Qingdao, , China
Investigational Site Number 156024, Shanghai, , China
Investigational Site Number 156028, Shanghai, , China
Investigational Site Number 156020, Shanghai, , China
Investigational Site Number 156011, Shanghai, , China
Investigational Site Number 156013, Shantou, , China
Investigational Site Number 156012, Suzhou, , China
Investigational Site Number 156004, Xi'An, , China
Investigational Site Number 156009, Xi'An, , China
Investigational Site Number 156027, Yinchuan, , China
Investigational Site Number 170010, Bogota, , Colombia
Investigational Site Number 170005, Manizales, , Colombia
Investigational Site Number 170002, Medellin, , Colombia
Investigational Site Number 170006, Medellin, , Colombia
Investigational Site Number 170007, Medellín, , Colombia
Investigational Site Number 170008, Monteria, , Colombia
Investigational Site Number 170004, Pereira, , Colombia
Investigational Site Number 191006, Pula, , Croatia
Investigational Site Number 191005, Rijeka, , Croatia
Investigational Site Number 191007, Varazdin, , Croatia
Investigational Site Number 191003, Zadar, , Croatia
Investigational Site Number 191008, Zagreb, , Croatia
Investigational Site Number 191001, Zagreb, , Croatia
Investigational Site Number 191004, Zagreb, , Croatia
Investigational Site Number 203004, Hradec Kralove, , Czech Republic
Investigational Site Number 203008, Kolin, , Czech Republic
Investigational Site Number 203007, Nova Ves Pod Plesi, , Czech Republic
Investigational Site Number 203003, Praha 5, , Czech Republic
Investigational Site Number 208001, Herlev, , Denmark
Investigational Site Number 233001, Tallinn, , Estonia
Investigational Site Number 246001, Turku, , Finland
Investigational Site Number 250002, Antibes, , France
Investigational Site Number 250010, Colmar, , France
Investigational Site Number 250020, Gap, , France
Investigational Site Number 250005, Lille Cedex, , France
Investigational Site Number 250025, Lille Cedex, , France
Investigational Site Number 250012, Lille Cedex, , France
Investigational Site Number 250003, Lyon, , France
Investigational Site Number 250001, Marseille, , France
Investigational Site Number 250024, Montpellier Cedex, , France
Investigational Site Number 250006, Paris Cedex 10, , France
Investigational Site Number 250027, Paris Cedex 10, , France
Investigational Site Number 250004, Paris Cedex 14, , France
Investigational Site Number 250021, Reims, , France
Investigational Site Number 250019, Rouen, , France
Investigational Site Number 250017, Saint Gregoire, , France
Investigational Site Number 250014, Vandoeuvre Les Nancy, , France
Investigational Site Number 276012, Augsburg, , Germany
Investigational Site Number 276025, Berlin, , Germany
Investigational Site Number 276016, Berlin, , Germany
Investigational Site Number 276002, Berlin, , Germany
Investigational Site Number 276029, Berlin, , Germany
Investigational Site Number 276004, Bochum, , Germany
Investigational Site Number 276014, Dresden, , Germany
Investigational Site Number 276009, Dresden, , Germany
Investigational Site Number 276030, Essen, , Germany
Investigational Site Number 276005, Frankfurt Am Main, , Germany
Investigational Site Number 276032, Gauting, , Germany
Investigational Site Number 276038, Halle/Saale, , Germany
Investigational Site Number 276034, Halle, , Germany
Investigational Site Number 276037, Hamburg, , Germany
Investigational Site Number 276007, Hannover, , Germany
Investigational Site Number 276006, Köln, , Germany
Investigational Site Number 276020, Leer, , Germany
Investigational Site Number 276010, Leipzig, , Germany
Investigational Site Number 276017, Magdeburg, , Germany
Investigational Site Number 276011, Mannheim, , Germany
Investigational Site Number 276003, Minden, , Germany
Investigational Site Number 276021, München, , Germany
Investigational Site Number 276019, München, , Germany
Investigational Site Number 276015, München, , Germany
Investigational Site Number 276013, Neumünster, , Germany
Investigational Site Number 276022, Oldenburg, , Germany
Investigational Site Number 276035, Paderborn, , Germany
Investigational Site Number 276031, Passau, , Germany
Investigational Site Number 276023, Rosenheim, , Germany
Investigational Site Number 276008, Singen, , Germany
Investigational Site Number 276024, Westerstede, , Germany
Investigational Site Number 300004, Athens, , Greece
Investigational Site Number 300003, Heraklion, , Greece
Investigational Site Number 300002, Thessaloniki, , Greece
Investigational Site Number 344001, Hong Kong, , Hong Kong
Investigational Site Number 348005, Budapest, , Hungary
Investigational Site Number 348006, Budapest, , Hungary
Investigational Site Number 348009, Budapest, , Hungary
Investigational Site Number 348004, Budapest, , Hungary
Investigational Site Number 348010, Farkasgyepu, , Hungary
Investigational Site Number 348001, Gyula, , Hungary
Investigational Site Number 348012, Mátraháza, , Hungary
Investigational Site Number 348003, Sopron, , Hungary
Investigational Site Number 348008, Szikszó, , Hungary
Investigational Site Number 348011, Szolnok, , Hungary
Investigational Site Number 348007, Zalaegerszeg, , Hungary
Investigational Site Number 356006, Bangalore, , India
Investigational Site Number 356008, Bangalore, , India
Investigational Site Number 356009, Bhopal, , India
Investigational Site Number 356018, Chennai, , India
Investigational Site Number 356020, Chennai, , India
Investigational Site Number 356019, Coimbatore, , India
Investigational Site Number 356015, Hyderabad, , India
Investigational Site Number 356025, Hyderabad, , India
Investigational Site Number 356011, Jaipur, , India
Investigational Site Number 356014, Kochi, , India
Investigational Site Number 356003, Kolkata, , India
Investigational Site Number 356013, Kolkata, , India
Investigational Site Number 356017, Kolkata, , India
Investigational Site Number 356005, Madurai, , India
Investigational Site Number 356016, Miraj, , India
Investigational Site Number 356001, Mumbai, , India
Investigational Site Number 356023, Nagpur, , India
Investigational Site Number 356002, New Delhi, , India
Investigational Site Number 356004, Pune, , India
Investigational Site Number 356024, Pune, , India
Investigational Site Number 356012, Vishakhapatnam, , India
Investigational Site Number 360002, Bandung, , Indonesia
Investigational Site Number 360001, Denpasar, , Indonesia
Investigational Site Number 360004, Medan, , Indonesia
Investigational Site Number 372004, Dublin 7, , Ireland
Investigational Site Number 372003, Dublin, , Ireland
Investigational Site Number 372002, Dublin, , Ireland
Investigational Site Number 376003, Jerusalem, , Israel
Investigational Site Number 376004, Kfar Saba, , Israel
Investigational Site Number 376001, Nahariya, , Israel
Investigational Site Number 376006, Petah-Tikva, , Israel
Investigational Site Number 376007, Tzrifin, , Israel
Investigational Site Number 380005, Castellanza, , Italy
Investigational Site Number 380014, Cattolica, , Italy
Investigational Site Number 380007, Cesena, , Italy
Investigational Site Number 380015, Cremona, , Italy
Investigational Site Number 380009, Faenza, , Italy
Investigational Site Number 380012, Lecce, , Italy
Investigational Site Number 380006, Lugo, , Italy
Investigational Site Number 380001, Meldola, , Italy
Investigational Site Number 380011, Parma, , Italy
Investigational Site Number 380020, Perugia, , Italy
Investigational Site Number 380013, Ravenna, , Italy
Investigational Site Number 380016, Rimini, , Italy
Investigational Site Number 380004, Sondrio, , Italy
Investigational Site Number 380010, Sora, , Italy
Investigational Site Number 380008, Taormina, , Italy
Investigational Site Number 380019, Terni, , Italy
Investigational Site Number 380003, Treviglio, , Italy
Investigational Site Number 380017, Udine, , Italy
Investigational Site Number 410008, Daegu, , Korea, Republic of
Investigational Site Number 410007, Seoul, , Korea, Republic of
Investigational Site Number 410001, Seoul, , Korea, Republic of
Investigational Site Number 410002, Seoul, , Korea, Republic of
Investigational Site Number 410006, Seoul, , Korea, Republic of
Investigational Site Number 410005, Seoul, , Korea, Republic of
Investigational Site Number 410003, Seoul, , Korea, Republic of
Investigational Site Number 410009, Seoul, , Korea, Republic of
Investigational Site Number 410004, Suwon, , Korea, Republic of
Investigational Site Number 428002, Liepaja, , Latvia
Investigational Site Number 428003, Riga, , Latvia
Investigational Site Number 428001, Riga, , Latvia
Investigational Site Number 440001, Kaunas, , Lithuania
Investigational Site Number 440002, Vilnius, , Lithuania
Investigational Site Number 458001, Kota Kinabalu, , Malaysia
Investigational Site Number 458003, Kuala Lumpur, , Malaysia
Investigational Site Number 458004, Penang, , Malaysia
Investigational Site Number 458005, Penang, , Malaysia
Investigational Site Number 484002, Acapulco, , Mexico
Investigational Site Number 484006, Aguascalientes, , Mexico
Investigational Site Number 484007, Durango, , Mexico
Investigational Site Number 484008, Mérida, , Mexico
Investigational Site Number 484012, Puebla, , Mexico
Investigational Site Number 484003, Toluca, , Mexico
Investigational Site Number 484010, Xalapa, , Mexico
Investigational Site Number 528006, Den Haag, , Netherlands
Investigational Site Number 528004, Groningen, , Netherlands
Investigational Site Number 528005, Helmond, , Netherlands
Investigational Site Number 528001, Hoofddorp, , Netherlands
Investigational Site Number 528003, Rotterdam, , Netherlands
Investigational Site Number 578001, Oslo, , Norway
Investigational Site Number 604012, Arequipa, , Peru
Investigational Site Number 604004, Callao, , Peru
Investigational Site Number 604011, Callao, , Peru
Investigational Site Number 604001, Cercado, , Peru
Investigational Site Number 604002, Chiclayo, , Peru
Investigational Site Number 604008, Lima, , Peru
Investigational Site Number 604007, Lima, , Peru
Investigational Site Number 604009, Lima, , Peru
Investigational Site Number 604005, Lima, , Peru
Investigational Site Number 604006, Lima, , Peru
Investigational Site Number 604010, Lima, , Peru
Investigational Site Number 604003, Lima, , Peru
Investigational Site Number 616009, Bialystok, , Poland
Investigational Site Number 616008, Bielsko-Biala, , Poland
Investigational Site Number 616006, Gliwice, , Poland
Investigational Site Number 616004, Krakow, , Poland
Investigational Site Number 616003, Lubin, , Poland
Investigational Site Number 616019, Olsztyn, , Poland
Investigational Site Number 616021, Otwock, , Poland
Investigational Site Number 616010, Poznan, , Poland
Investigational Site Number 616001, Prabuty, , Poland
Investigational Site Number 616014, Rybnik, , Poland
Investigational Site Number 616005, Rzeszow, , Poland
Investigational Site Number 616013, Torun, , Poland
Investigational Site Number 616018, Warszawa, , Poland
Investigational Site Number 616002, Warszawa, , Poland
Investigational Site Number 616015, Wroclaw, , Poland
Investigational Site Number 620003, Aveiro, , Portugal
Investigational Site Number 620009, Guimarães, , Portugal
Investigational Site Number 620004, Lisboa, , Portugal
Investigational Site Number 620008, Matosinhos, , Portugal
Investigational Site Number 620007, Porto, , Portugal
Investigational Site Number 620002, Setúbal, , Portugal
Investigational Site Number 642004, Brasov, , Romania
Investigational Site Number 642002, Bucuresti, , Romania
Investigational Site Number 642001, Cluj Napoca, , Romania
Investigational Site Number 642006, Cluj-Napoca, , Romania
Investigational Site Number 642010, Iasi, , Romania
Investigational Site Number 642003, Suceava, , Romania
Investigational Site Number 642008, Timisoara, , Romania
Investigational Site Number 643024, Berdsk, , Russian Federation
Investigational Site Number 643006, Chelyabinsk, , Russian Federation
Investigational Site Number 643001, Kazan, , Russian Federation
Investigational Site Number 643004, Krasnoyarsk, , Russian Federation
Investigational Site Number 643010, Obninsk, , Russian Federation
Investigational Site Number 643005, Omsk, , Russian Federation
Investigational Site Number 643022, Pyatigorsk, , Russian Federation
Investigational Site Number 643023, Rostov-On-Don, , Russian Federation
Investigational Site Number 643020, Saratov, , Russian Federation
Investigational Site Number 643019, Smolensk, , Russian Federation
Investigational Site Number 643021, Sochi, , Russian Federation
Investigational Site Number 643014, St-Petersburg, , Russian Federation
Investigational Site Number 643015, St-Petersburg, , Russian Federation
Investigational Site Number 643011, St-Petersburg, , Russian Federation
Investigational Site Number 643009, St.Petersburg, , Russian Federation
Investigational Site Number 643008, Tomsk, , Russian Federation
Investigational Site Number 643016, Tula, , Russian Federation
Investigational Site Number 643018, Tyumen, , Russian Federation
Investigational Site Number 643012, Ufa, , Russian Federation
Investigational Site Number 643007, Vladivostok, , Russian Federation
Investigational Site Number 643017, Voronezh, , Russian Federation
Investigational Site Number 643003, Yaroslavl, , Russian Federation
Investigational Site Number 688002, Belgrade, , Serbia
Investigational Site Number 688004, Belgrade, , Serbia
Investigational Site Number 688007, Kragujevac, , Serbia
Investigational Site Number 688005, Nis, , Serbia
Investigational Site Number 703003, Trnava, , Slovakia
Investigational Site Number 705003, Golnik, , Slovenia
Investigational Site Number 705002, Maribor, , Slovenia
Investigational Site Number 710003, Durban, , South Africa
Investigational Site Number 710002, Durban, , South Africa
Investigational Site Number 724008, Barakaldo, , Spain
Investigational Site Number 724010, Barakaldo, , Spain
Investigational Site Number 724004, Barcelona, , Spain
Investigational Site Number 724006, Islas Baleares, , Spain
Investigational Site Number 724011, Lérida, , Spain
Investigational Site Number 724001, Madrid, , Spain
Investigational Site Number 724007, Madrid, , Spain
Investigational Site Number 724013, Madrid, , Spain
Investigational Site Number 724012, Madrid, , Spain
Investigational Site Number 724005, Orense, , Spain
Investigational Site Number 724003, Puerto De Sagunto, , Spain
Investigational Site Number 724002, Valencia, , Spain
Investigational Site Number 752003, Göteborg, , Sweden
Investigational Site Number 752005, Mora, , Sweden
Investigational Site Number 752002, Uppsala, , Sweden
Investigational Site Number 752001, Växjö, , Sweden
Investigational Site Number 756006, Aarau, , Switzerland
Investigational Site Number 756004, Winterthur, , Switzerland
Investigational Site Number 158004, Changhua, , Taiwan
Investigational Site Number 804008, Cherkasy, , Ukraine
Investigational Site Number 804009, Chernivtsi, , Ukraine
Investigational Site Number 804002, Dnipropetrovsk, , Ukraine
Investigational Site Number 804006, Donetsk, , Ukraine
Investigational Site Number 804005, Krivoy Rog, , Ukraine
Investigational Site Number 804001, Lutsk, , Ukraine
Investigational Site Number 804010, Lviv, , Ukraine
Investigational Site Number 804011, Sumy, , Ukraine
Investigational Site Number 804004, Ternopil, , Ukraine
Investigational Site Number 826016, Bangor, , United Kingdom
Investigational Site Number 826010, Brighton, , United Kingdom
Investigational Site Number 826015, Coventry, , United Kingdom
Investigational Site Number 826013, Dundee, , United Kingdom
Investigational Site Number 826007, Hull, , United Kingdom
Investigational Site Number 826002, Lincoln, , United Kingdom
Investigational Site Number 826017, Lincoln, , United Kingdom
Investigational Site Number 826005, Manchester, , United Kingdom
Investigational Site Number 826004, Norwich, , United Kingdom
Investigational Site Number 826009, Peterborough, , United Kingdom
Investigational Site Number 826011, Portsmouth, , United Kingdom
Investigational Site Number 826001, Shrewsbury, , United Kingdom
Investigational Site Number 826014, Wirral, , United Kingdom
Name: Alexander Turpie, MD
Affiliation: HHS-General Hospital, Hamilton, Canada
Role: STUDY_CHAIR
Name: Giancarlo Agnelli, MD
Affiliation: University Of Perugia
Role: PRINCIPAL_INVESTIGATOR